BM Medical QR-26-002(V1.

1)

Contract Review Form

Customer Code: 2047 Initiation Date: 04-05-2023 No: S0202305040003

Product Name Specifications and Models Quantity Unit Remarks

Single-use Endoscopic Linear Cutting ENDO BLC L 300.000 Pcs

Stapler and Components (Body)

Single-use Linear Cutting Stapler and BLCB 60 200.000 Pcs

Components (Body)

Single-use Linear Stapler and BLS 30 200.000 Pcs

Components (Body)

Single-use Linear Stapler and BLS 60 100.000 Pcs

Order Components (Body)
Information Single-use Linear Stapler and BLS 45 200.000 Pcs
Components (Body)

Single-use Linear Stapler and BLS 90 50.000 Pcs

Components (Body)

Staple Cartridge Assembly BLS 3035L 600.000 Pcs

Staple Cartridge Assembly BLS 3048L 600.000 Pcs
Staple Cartridge Assembly BLS 4535L 600.000 Pcs
Staple Cartridge Assembly BLS 4548L 700.000 Pcs
Staple Cartridge Assembly BLS 6035L 600.000 Pcs
Staple Cartridge Assembly BLS 6048L 600.000 Pcs
Staple Cartridge Assembly BLS 9035L 600.000 Pcs
Staple Cartridge Assembly BLS 9048L 600.000 Pcs

1) The quality of the delivered products shall comply with: Our company's technical requirements Standard requirements.
Technical 2) Packaging Requirement: According to the work instructions
Requirements 3) Packaging and Printing Requirement: According to the work instructions
4) Delivery time: 30 Working days
5) Other Requirements:

Product Evaluation: □ Standard Product □ Non-standard Product (Non-certified/Products developed within the past year, etc.)
Order Evaluation: □ Standard Order :
□ Special Order: □ Part Form □ Assembly Form □ Non-sterile Finished Product □ Customized (Color, Packaging, etc.)

Marketing Center/Date: Gu Yuehua 2023-05-04

Delivery Status: Part of the shipment is expected to be completed within 30 days.

Production Planning Department/Date: 04-05-2023

Page 1 of 2
 BM Medical QR-26-002(V1.1)

Material Inventory Status:

Warehouse and Logistics Department/Date: 04-05-2023

Technical Requirements Evaluation:

Technical Department/Date: 04-05-2023

Quality Standard Evaluation;

Quality Department/Date: 04-05-2023

Material Procurement:

Purchasing Department/Date: 04-05-2023

Delivery Compliance Status:

Manufacturing Department/Date: 04-05-2023

Review Conclusion:

Approver/Date: 04-05-2023

Retention Period: Long-Term

Page 2 of 2

 Page 2
 Production Order Input
Processing Type: Assembly Production Order Number: PA202305050002 Document date: 05-05-2023

No. Production Material Material Material Product Unit Quantity Completion Department Customer Remark
Specification Code
Batch No. Code Name Category Date Name

1 230504-15 C030030300 Single-use Endoscopic Linear ENDO BLC Endoscopic Stapler Pcs 301.00 04-05-2023 Stapler Division 2074 Retain 1
Cutting Stapler and Product sample
L
Components (Body)
2 230504-16 B110130030 Single-use Endoscopic Linear BLCB 60 Open Stapler Product Pcs 201.00 04-05-2023 Stapler Division 2074 Retain 1
Cutting Stapler and sample
Components (Body)
3 230504-17 B100090100 Single-use Linear Stapler BLS 30 Pcs 201.00 04-05-2023 Stapler Division 2074 Retain 1
sample
and Components (Body)

4 230504-18 B100110100 Single-use Linear Stapler BLS 60 Endoscopic Stapler Pcs 101.00 04-05-2023 Stapler Division 2074 Retain 1
Product sample
and Components (Body)

5 230504-19 B100100020 Single-use Linear Stapler BLS 45 Open Stapler Product Pcs 201.00 04-05-2023 Stapler Division 2074 Retain 1
sample
and Components (Body)

6 230504-20 B100120100 Single-use Linear Stapler BLS 90 Open Stapler Product Pcs 51.00 04-05-2023 Stapler Division 2074 Retain 1
sample
and Components (Body)

7 230504-21 B100010007 Staple Cartridge Assembly BLS 3035L Open Stapler Product Pcs 601.00 04-05-2023 Stapler Division 2074 Retain 1
sample
8 230504-22 B100020009 Staple Cartridge Assembly BLS 3048L Open Stapler Product Pcs 601.00 04-05-2023 Stapler Division 2074 Retain 1
sample
9 230504-23 B100030011 Staple Cartridge Assembly BLS 4535L Open Stapler Product Pcs 601.00 04-05-2023 Stapler Division 2074 Retain 1
sample
10 230504-24 B100040012 Staple Cartridge Assembly BLS 4548L Open Stapler Product Pcs 701.00 04-05-2023 Stapler Division 2074 Retain 1
sample
11 230504-25 B100050013 Staple Cartridge Assembly BLS 6035L Open Stapler Product Pcs 601.00 04-05-2023 Stapler Division 2074 Retain 1
sample
12 230504-26 B100060014 Staple Cartridge Assembly BLS 6048L Open Stapler Product Pcs 601.00 04-05-2023 Stapler Division 2074 Retain 1
sample
13 230504-27 B100070015 Staple Cartridge Assembly BLS 9035L Open Stapler Product Pcs 601.00 04-05-2023 Stapler Division 2074 Retain 1
sample
14 230504-28 B100080016 Staple Cartridge Assembly BLS 9048L Open Stapler Product Pcs 601.00 04-05-2023 Stapler Division 2074 Retain 1
sample

Note: According to the 2074 customer work instructions, production, pad printing, packaging.

Document Creator:

Marketing Department: Production Department: Warehouse:

 Material Dispatch Note
Outgoing order number IM202305180021 Release date 18-05-2023 Warehouse: Raw Materials Warehouse

Order Number PA202305050002 Product Specifications ENDO BLC L Production batch Number: 230504-15

Outsourcing Outbound category: Material Requisition outbound Department: Stapler Division

Product Name: Single-use Endoscopic Linear Cutting Customer Code: 2074 Remarks: Retain 1 sample

Stapler and Components (Body)

Material Code Material Name Specifications and Models Quantity Unit Batch Number
Y020010043 Upper Rotating Head ENDO BLC General 175.00 Pcs C10011230505014
Y010020044 Steering Plate ENDO BLC General 301.00 Pcs C10175230417014
Y020010038 Steering Knob ENDO BLC General - Milky White 301.00 Pcs C10016230419018
Y010020037 Steering Knob Pin ENDO BLC General 301.00 Pcs C10053230412019
Y020010084 Steering Lock ENDO BLC General 301.00 Pcs C10016230419020
Y010021317 Steering Bracket Assembly ENDO BLC General - Recessed 234.00 Pcs C10012230404014
Version
Y01002000201 Firing Rod ENDO BLC L - Thickness: 3.2, 7.30 Pcs C10006230415002
Chamfer 90 Degrees
Y01002000201 Firing Rod ENDO BLC L - Thickness: 3.2, 271 Pcs C10006230511016
Chamfer 90 Degrees
Y020020015 Firing Rod Sealing Ring ENDO BLC/ECB General 301.00 Pcs C10021230408030
Y010020010 Firing Rod Sleeve ENDO BLC L 301.00 Pcs C10078230515010
Y020010013 Barrel Rear Seat ENDO BLC General 301.00 Pcs C10016230505004
Y020020012 Sealing Clamp ENDO BLC General 301.00 Pcs C10040221021005
Y01002000705 Staple Advancing Plate ENDO BLC M/L General - 301.00 Pcs C10019230330031
Thickness: 0.9
Y020010006 Advancing Plate Positioning Block ENDO BLC General 301.00 Pcs C10016230419022
B030010006 Cartridge Locking Plate Assembly ENDO BLC General Elevated 0.01 Pcs
B030010006 Cartridge Locking Plate Assembly ENDO BLC General Elevated 0.01 301.00 Pcs C10175230417011
Y020010036 Cartridge Locking Button ENDO BLC General 301.00 Pcs C10016230419023
Y010030030 Locking Button Spring ENDO BLC General 301.00 Pcs C10010230415008
Y020020014 Barrel Core Sealing Ring ENDO BLC/ECB General 301.00 Pcs C10040221011011
Y020010034 Barrel Core Connecting Rod ENDO BLC L 301.00 Pcs C10014230510020
Y020010035 Barrel Core Connecting Plate ENDO BLC L 602.00 Pcs C10014230510021
Subtotal 5881.00
Total 13838.00

Document Creator: Reviewer: Issuer: Recipient:

 Material Dispatch Note
Outgoing order number IM202305180021 Release date 18-05-2023 Warehouse: Raw Materials Warehouse

Order Number PA202305050002 Product Specifications ENDO BLC L Production batch Number: 230504-15

Outsourcing Outbound category: Material Requisition outbound Department: Stapler Division

Product Name: Single-use Endoscopic Linear Cutting Customer Code: 2074 Remarks: Retain 1 sample

Stapler and Components (Body)

Material Code Material Name Specifications and Models Quantity Unit Batch Number
Y020010062 Trigger ENDO BLC General 301.00 Pcs C10016230503001
Y010020064 Advancer ENDO BLC General 301.00 Pcs C10175230411012
Y010030065 Advancer Spring ENDO BLC General 301.00 Pcs C10010230202002
YO10020066 Advancer Rivet ENDO BLC General 301.00 Pcs C10053230315016
Y010030067 Trigger Reset Spring ENDO BLC General 301.00 Pcs C10010230415004
Y020010069 Safety Button ENDO BLC General 301.00 Pcs C10016230419013
Y010030072 Safety Button Spring ENDO BLC General – New Model 602.00 Pcs 20210315029
Y010030075 Safety Lock Plate Spring ENDO BLC General 301.00 Pcs C10010230209002
Y020010080 Right Reset Cap ENDO BLC General 301.00 Pcs C10016230419015
Y020010083 left Reset Cap ENDO BLC General 301.00 Pcs C10016230419014
Y010020059 Reset Pin ENDO BLC General 301.00 Pcs C10040230206019
Y010020060 Reset Hook ENDO BLC General 301.00 Pcs C10175230412023
Y010030061 Reset Spring ENDO BLC General 301.00 Pcs C10010230315017
Y020010053 Advancing Rack ENDO BLC General 301.00 Pcs C10011220715018
Y010020057 Reset Plate ENDO BLC General 301.00 Pcs C10175230413009
Y010020058A Reset Plate Positioning Pin ENDO BLC/ECB General 602.00 Pcs C10053230412018
Y020010051 Positioner ENDO BLC General 301.00 Pcs C10016230509001
Y010030052 Positioner Plate ENDO BLC General 301.00 Pcs C10010230513001
Y020010049 Staple Safety ENDO BLC General 293.00 Pcs 101036230411024
Y010030050 Staple Safety Spring ENDO BLC General 301.00 Pcs C10010230415006
Y020010076 Staple Safety Rod ENDO BLC General - Thickened 301.00 Pcs C10016230419017
Y010030077 Safety Rod Spring ENDO BLC General 301.00 Pcs C10010230415007
Y020020048 Rotating Head Sealing Ring ENDO BLC/ECB General 301.00 Pcs C10040230414024

Y020010085 Lower Rotating Head ENDO BLC General 126.00 Pcs C10011230505015
Y020010085 Lower Rotating Head ENDO BLC General 175 Pcs C10011230505013
Y020010043 Upper Rotating Head ENDO BLC General 126 Pcs C10011230505016
7957.00
Document Creator: Reviewer: Issuer: Recipient:

Printer/Number of Prints/Printing Time Que Mengjia/1/18-05-2023 09:24:32

 Page 5
 Material Dispatch Note
Outgoing order number IM202305190053 Release date 19-05-2023 Warehouse: Raw Materials Warehouse

Order Number PA202305050002 Product Specifications ENDO BLC L Production batch Number: 230504-15

Outsourcing Outbound category: Material Requisition outbound Department: Stapler Division

Product Name: Single-use Endoscopic Linear Cutting Customer Code: 2074 Remarks: Retain 1 sample

Stapler and Components (Body)

Material Code Material Name Specifications and Models Quantity Unit Batch Number
Y020010045 Steering Block ENDO BLC General 301.00 Pcs 101036230411023
Subtotal 301.00
Total 301.00

Document Creator: Reviewer: Issuer: Recipient:

Printer/Number of Prints/Printing Time Que Mengjia/1/19-05-2023 10:12:23

Material Dispatch Note

Outgoing order number IM202305170032 Release date 17-05-2023 Warehouse: Raw Materials Warehouse

Order Number PA202305050002 Product Specifications ENDO BLC L Production batch Number: 230504-15

Outsourcing Outbound category: Material Requisition outbound Department: Stapler Division

Product Name: Single-use Endoscopic Linear Cutting Customer Code: 2074 Remarks: Retain 1 sample

Stapler and Components (Body)

Material Code Material Name Specifications and Models Quantity Unit Batch Number
Y020010078 Left Outer Shell ENDO BLC General - Blank 122.00 Pcs C10011230505011
Y020010078 Left Outer Shell ENDO BLC General – Blank 179.00 Pcs C10011230505009
Y020010081 Right Outer Shell ENDO BLC General – Blank 122.00 Pcs C10011230505012
Y020010081 Right Outer Shell ENDO BLC General – Blank 179.00 Pcs C10011230505010
Y020010004 Barrel Core ENDO BLC M/L – Assembly Size 301.00 Pcs C10011230418011
4.24
Subtotal 903.00 Pcs
Total 903.00 Pcs

Document Creator: Reviewer: Issuer: Recipient:

Printer/Number of Prints/Printing Time Que Mengjia/1/17-05-2023 11:13:11

 Material Dispatch Note
Outgoing order number IM202305230062 Release date 23-05-2023 Warehouse: Raw Materials Warehouse

Order Number PA202305050002 Product Specifications ENDO BLC L Production batch Number: 230504-15

Outsourcing Outbound category: Material Requisition outbound Department: Stapler Division

Product Name: Single-use Endoscopic Linear Cutting Customer Code: 2074 Remarks: Retain 1 sample

Stapler and Components (Body)

Material Code Material Name Specifications and Models Quantity Unit Batch Number
Y010021317 Steering Bracket Assembly ENDO BLC General Recessed 67.00 Pcs C10012230523006
Version
Subtotal 67.00
Total 67.00

Document Creator: Reviewer: Issuer: Recipient:

Printer/Number of Prints/Printing Time Que Mengjia/1/23-05-2023 14:22:56

Material Dispatch Note

Outgoing order number IM202305240043 Release date 24-05-2023 Warehouse: Raw Materials Warehouse

Order Number PA202305050002 Product Specifications ENDO BLC L Production batch Number: 230504-15

Outsourcing Outbound category: Material Requisition outbound Department: Stapler Division

Product Name: Single-use Endoscopic Linear Cutting Customer Code: 2074 Remarks: Retain 1 sample

Stapler and Components (Body)

Material Code Material Name Specifications and Models Quantity Unit Batch Number
Y010020032 Steering Bracket Assembly ENDO BLC L 138.00 Pcs C10019230523025
Subtotal 138.00
Total 138.00

Document Creator: Reviewer: Issuer: Recipient:

Printer/Number of Prints/Printing Time Que Mengjia/1/24-05-2023 10:18:44

 Page 7
 Material Dispatch Note
Outgoing order number IM202305220078 Release date 22-05-2023 Warehouse: Raw Materials Warehouse

Order Number PA202305050002 Product Specifications ENDO BLC L Production batch Number: 230504-15

Outsourcing Outbound category: Material Requisition outbound Department: Stapler Division

Product Name: Single-use Endoscopic Linear Cutting Customer Code: 2074 Remarks: Retain 1 sample

Stapler and Components (Body)

Material Code Material Name Specifications and Models Quantity Unit Batch Number
Y010020032 Steering Bracket Assembly ENDO BLC L 163.00 Pcs C10019230522042
Subtotal 163.00
Total 163.00

Document Creator: Reviewer: Issuer: Recipient:

Printer/Number of Prints/Printing Time Que Mengjia/1/22-05-2023 15:19:49

Material Dispatch Note

Outgoing order number IM202305220064 Release date 24-05-2023 Warehouse: Outsourced Processing Storage (1)

Order Number PA202305050002 Product Specifications ENDO BLC L Production batch Number: 230504-15

Outsourcing Outbound category: Material Requisition outbound Department: Stapler Division

Product Name: Single-use Endoscopic Linear Cutting Customer Code: 2074 Remarks: Retain 1 sample

Stapler and Components (Body)

Material Code Material Name Specifications and Models Quantity Unit Batch Number
B030030020 Barrel Outer Shell ENDO BLC L - Darker 301.00 Pcs C10019230522041
Subtotal 301.00
Total 301.00

Document Creator: Reviewer: Issuer: Recipient:

Printer/Number of Prints/Printing Time Que Mengjia/1/22-05-2023 14:42:28

 Page 8
 Material Dispatch Note
Outgoing order number IM202305220051 Release date 22-05-2023 Warehouse: Raw Materials Warehouse

Order Number PA202305050002 Product Specifications ENDO BLC L Production batch Number: 230504-15

Outsourcing Outbound category: Material Requisition outbound Department: Stapler Division

Product Name: Single-use Endoscopic Linear Cutting Customer Code: 2074 Remarks: Retain 1 sample

Stapler and Components (Body)

Material Code Material Name Specifications and Models Quantity Unit Batch Number
Y020010073 Safety Lock Plate ENDO BLC General 301.00 Pcs 101036230522004
Y020010049 Staple Safety ENDO BLC General 8.00 Pcs 101036230522003
Subtotal 309.00
Total 309.00

Document Creator: Reviewer: Issuer: Recipient:

Printer/Number of Prints/Printing Time Que Mengjia/1/22-05-2023 14:09:45

Material Dispatch Note

Outgoing order number IM202305260067 Release date 26-05-2023 Warehouse Corpus

Order Number PA202305050002 Product Specifications ENDO BLC L Production batch Number: 230504-15

Outsourcing Outbound category: Material Requisition outbound Department: Stapler Division

Product Name: Single-use Endoscopic Linear Cutting Customer Code: 2074 Remarks: Retain 1 sample

Stapler and Components (Body)

Material Code Material Name Specifications and Models Quantity Unit Batch Number
Y020010085 Lower Rotating Head ENDO BLC General -15.00 Pcs C10011230505015
Y020010043 Upper Rotating Head ENDO BLC General -15.00 Pcs C10011230505014
Subtotal -30.00
Total -30.00

Document Creator: Reviewer: Issuer: Recipient:

Printer/Number of Prints/Printing Time Que Mengjia/1/26-05-2023 15:00:35

 Page 9
 Material Dispatch Note
Outgoing order number IM202305260068 Release date 26-05-2023 Warehouse: Raw Materials Warehouse

Order Number PA202305050002 Product Specifications ENDO BLC L Production batch Number: 230504-15

Outsourcing Outbound category: Material Requisition outbound Department: Stapler Division

Product Name: Single-use Endoscopic Linear Cutting Customer Code: 2074 Remarks: Retain 1 sample

Stapler and Components (Body)

Material Code Material Name Specifications and Models Quantity Unit Batch Number
Y020010085 Lower Rotating Head ENDO BLC General 15.00 Pcs C10011230505015
Y020010043 Upper Rotating Head ENDO BLC General 15.00 Pcs C10011230505014
Subtotal 30.00
Total 30.00

Document Creator: Reviewer: Issuer: Recipient:

Printer/Number of Prints/Printing Time Que Mengjia/1/26-05-2023 15:00:53

Material Dispatch Note

Outgoing order number IM202305260065 Release date 17-05-2023 Warehouse Corpus

Order Number PA202305050002 Product Specifications ENDO BLC L Production batch Number: 230504-15

Outsourcing Outbound category: Material Requisition outbound Department: Stapler Division

Product Name: Single-use Endoscopic Linear Cutting Customer Code: 2074 Remarks: Retain 1 sample

Stapler and Components (Body)

Material Code Material Name Specifications and Models Quantity Unit Batch Number
Y020010078 Left Outer Shell ENDO BLC General - Blank -3.00 Pcs C10011230505009
Y020010081 Right Outer Shell ENDO BLC General – Blank -3.00 Pcs C10011230505010
Subtotal -6.00
Total -6.00

Document Creator: Reviewer: Issuer: Recipient:

Printer/Number of Prints/Printing Time Que Mengjia/1/26-05-2023 14:58:41

 Page 10
 Material Dispatch Note
Outgoing order number IM202305260066 Release date 26-05-2023 Warehouse: Raw Materials Warehouse

Order Number PA202305050002 Product Specifications ENDO BLC L Production batch Number: 230504-15

Outsourcing Outbound category: Material Requisition outbound Department: Stapler Division

Product Name: Single-use Endoscopic Linear Cutting Customer Code: 2074 Remarks: Retain 1 sample

Stapler and Components (Body)

Material Code Material Name Specifications and Models Quantity Unit Batch Number
Y020010078 Left Outer Shell ENDO BLC General - Blank 3.00 Pcs C10011230505009
Y020010081 Right Outer Shell ENDO BLC General – Blank 3.00 Pcs C10011230505010
Subtotal 6.00
Total 6.00

Document Creator: Reviewer: Issuer: Recipient:

Printer/Number of Prints/Printing Time Que Mengjia/1/26-05-2023 14:58:57

Material Dispatch Note

Outgoing order number IM202305250047 Release date 25-05-2023 Warehouse Packaging Materials Storage

Order Number PA202305050002 Product Specifications ENDO BLC L Production batch Number: 230504-15

Outsourcing Outbound category: Material Requisition outbound Department: Stapler Division

Product Name: Single-use Endoscopic Linear Cutting Customer Code: 2074 Remarks: Retain 1 sample

Stapler and Components (Body)

Material Code Material Name Specifications and Models Quantity Unit Batch Number
E010010001 Blister Box ENDO BLC/General for Instruments 315.00 Pcs C10017230517013
E010010005 Cover Plate ENDO BLC/General for Instruments 315.00 Pcs C10017230517014
E010020002 Dialysis Paper ENDO BLC/General for Instruments 330.00 Pcs 0000
E010030003 Inner Packaging ENDO BLC/General for Instruments 300.00 Pcs C10041230513012
E010040017 Outer Packaging ENDO BLC L 30.00 Pcs C10041230509030
Subtotal 1290.00
Total 1290.00

Document Creator: Reviewer: Issuer: Recipient:

Printer/Number of Prints/Printing Time Que Mengjia/1/25-05-2023 14:03:55

 Page 11
 Cleaning Records
Record Number: QR—21--010 (V2.0)

Production Batch Number 230504-15 Customer Code: 2074

Serial Material Name Batch Number Quantity Remark

Number
1 Thruster C10175230411012 301

2 Thruster Rivet C10053230315016 301

3 Reser Pin C10040230206019 301
4 Reset Hook C10175230412023 301
5 Reset Plate C10175230413009 301
6 Reser Plate Positioning Pin C10053230412018 602
7 Steering Plate C10175230417014 301
8 Steering knob Pin C10053230412019 301
9 Steering Bracket Assembly C10012230404014 234 C10012230523006
10 Steering Linkage C10019230522042 165+138 C10019230523021
11 Firing Pin C10006230415002 30+271 C10006230511016
12 Firing Pin Sleeve C10078230515010 301
13 Barrel Outer Shell C10019230522041 301
14 Staple Advancing Plate C10019230330031 301
15 Staple Magazine Locking Plate Assembly C10175230417011 301
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
Parameters Detergent: 50ml Pre-wash Temperature: 50°C
Pre-Wash
Operator/ Date 20-05-2023

Parameters Fine Wash Drying Temperature:

Fine Wash and Drying Temperature: 50°C 70°C
Operator/ Date 20-05-2023

 Page 12
 Cleaning Records
Record Number: QR—21--010 (V2.0)

Production Batch Number 230504-15 Customer Code: 2074

Serial Material Name Batch Number Quantity Remark

Number
1 Trigger C10016230503001 301

2 Safety Button C10016230419013 301

3 Safety Lock Plate 101036230522004 301
4 Right Reset Cap C10016230419015 301
5 Left Reset Cap C10016230419014 301
6 Advancing Rack C10011220715018 301
7 Positioning Mechanism C10016230509001 301
8 Stapling Safety 101036230411024 293+8 101036230522003
9 Stapling safety Rod C10016230419017 301
10 Rotating Head Seal Ring C10040230414024 301
11 Lower Rotating Head C10011230505015 126+175 C10011230505013
12 Upper Rotating Head C10011230505016 126+175 C10011230505014
13 Steering Block 101036230411023 301
14 Steering Knob C10016230419018 301
15 Steering lock C10016230419020 301
16 Firing Pin Seal Ring C10021230408030 301
17 Barrel Backseat C10016230505004 301
18 Barrel Inner Core C10011230418011 301
19 Seal Clamp C10040221021005 301
20 Advancing Plate Positioning Block C10016230419022 301
21 Staple Magazine Locking Button C10016230419023 301
22 Barrel Inner Core C10040221011011 301
23 Left Outer Shell C10011230505011 122+179 C10011230505009
24 Right Outer shell C10011230505012 122+179 C10011230505010
25
26
27
28
29
30
31
32
Parameters Detergent: 50ml Pre-wash Temperature: 50°C
Pre-Wash
Operator/ Date 20-05-2023

Parameters Fine Wash Drying Temperature:

Fine Wash and Drying Temperature: 50°C 50°C
Operator/ Date 20-05-2023

 Page 13
 BM Medical Process with work order
Product Name: Single-use Endoscopic Linear Cutting Stapler and Components (Body) QR – 21 – 006 (V2.0)

Date: 24-05-2023 Production Batch Number: 230504 – 15 Model: ENDO BLC L Production Quantity: 301 Customer Code: 2074

Operation Operation Name Operation Content Qualified Defective Operator Start Time Equipment Equipment
Number Quantity Quantity Completion Time Number Parameters Remark

Reset Plate 22-05-2023 BM-P8014-02

Reset Plate
1-1 Assembly Rack Gear 301 0 9:30-11:00 0.7mpa
Reset Plate Locating Pin

1-1 22-05-2023
Reset Spring
1-2 Reser Hook 301 0 9:40-12:20
Assembly Reset Hook
Reset Pin
Trigger 21-05-2023

Trigger Component Pusher 301 12:00-15:00

2-1 Riveting Pusher Spring 0

Pusher Rivet
Firing Rod 24-05-2023

Firing Rod Sleeve Firing Rod Sleeve 301 0 8:00-14:00

3-1 Assembly Firing Rod Seal
Barrel Inner Core Seal
3-1 24-05-2023
Staple Pusher Plate
Assembly Staple Pusher Plate 301 0 8:00-14:00
3-2 Barrel Inner Core
Pusher Plate Locating Block
Cause of Defect:

Measures Taken:

Supervisor Confirmation:
 BM Medical Process with work order
Product Name: Single-use Endoscopic Linear Cutting Stapler and Components (Body) QR – 21 – 006 (V2.0)

Date: 24-05-2023 Production Batch Number: 230504 – 15 Model: ENDO BLC L Production Quantity: 301 Customer Code: 2074

Operation Operation Name Operation Content Qualified Defective Operator Start Time Equipment Equipment
Number Quantity Quantity Completion Time Number Parameters Remark
3-2 24-05-2023
3-3 Barrel Housing Barrel Housing 301 0 8:00-14:00
Assembly
Staple Cartridge Locking Button
Locking Button Spring
Staple Cartridge Locking Plate
Assembly
Steering Link Rod
3-3 24-05-2023
Barrel Recoil
3-4 Barrel Recoil Assembly 301 0 8:00-14:00
Sealing Clamp
Steering Block 21-05-2023
4-1 Upper Rotary Head
Steering Plate
Assembly 301 0 12:00-15:00
Upper Rotary Head
Staple Safety Rod 24-05-2023
Staple Safety Rod
Staple Rod Spring
5-1 Assembly 301 0 8:00-20:00
Right Outer Shell
2-1 24-05-2023
Trigger Component 5-1
5-2 Assembly 301 0 8:00-20:00
Trigger Reset Spring
5-2 24-05-2023
5-3 Staple Safety Assembly Staple Safety 301 0
8:00-20:00
Staple Safety Spring
Cause of Defect:

Measures Taken:

Supervisor Confirmation:

 Page 15
 BM Medical Process with work order
Product Name: Single-use Endoscopic Linear Cutting Stapler and Components(Body) QR – 21 – 006 (V2.0)

Date: 25-05-2023 Production Batch Number: 230504 – 15 Model: ENDO BLC L Production Quantity: 301 Customer Code: 2074

Operation Operation Name Operation Content Qualified Defective Operator Start Time Equipment Equipment
Number Quantity Quantity Completion Time Number Parameters Remark
5-3 24-05-2023
5-4 Assembly of Positioner 301 0 8:00-20:00
and Safety Button Positioner
Positioner Spring
Safety Button
Safety Button Spring
Assembly of Safety 5-4 24-05-2023
Lock Plate
Safety lock Plate
5-5 301 0 8:00-20:00
Safety lock Plate Spring
Assembly of Left Outer 5-5 24-05-2023
5-6 Shell
Left Outer Shell
301 0 8:00-20:00
Rotary Head Sealing Ring
Ultrasonic Welding 5-6
6-1 301 0 8:00-20:10

Installation of Gun 3-4

Barrel
7-1 6-1 301 0 8:00-20:10
Left Reset Cap
Right Reset Cap
Assembly of Upper and 7-1 25-05-2023
8-1 Lower Rotary Heads 301 0
Steering Bracket
8:00-16:00
Upper Rotary Head
Lower Rotary Head
Cause of Defect:

Measures Taken:

Supervisor Confirmation:

 Page 16
 BM Medical Process with work order
Product Name: Single-use Endoscopic Linear Cutting Stapler and Components (Body) QR – 21 – 006 (V2.0)

Date: 24-05-2023 Production Batch Number: 230504 – 15 Model: ENDO BLC L Production Quantity: 301 Customer Code: 2074

Operation Operation Name Operation Content Qualified Defective Operator Start Time Equipment Equipment
Number Quantity Quantity Completion Number Parameters Remark
Time
8-2 Ultrasonic Welding 8-1 301 0 25-05-2023 BM-P8003-10 0.7mpa

Steering Knob 8-2 301 0

Assembly 8:00-17:00
9-1 Rotary Knob
Rotary Knob Pin
301 0
10-1 Test Firing 9-1 8:00-16:00

Heat Sealing 11-1 BMP8002-06 Pressure:

11-2 Temperature:
Blister Box
Time:
Blister Paper
Packaging 11-2

12-1 Color Box

Certificate of Conformity
Instruction Manual

Cause of Defect:

Measures Taken:

Supervisor Confirmation:

 Page 17
 BM/QP23-B/00
BM Medical
First Article Inspection Record

Product Endoscopic Specification BLC Process Inspection Batch Number Production 24-05-
First Model
Name Instrument L Date 2023
Article
Inspection ☑ Start-up/ First Inspection ☐Mold Repair First Piece ☐First Piece Production
☐Changes In Production Parameters ☐ Material Changes ☐Others: ____ 230504 – 15 Inspection
Time 14:40
Project Measured Value Judgement Remarks
Inspection
Standards 1 2 3 4 5

8° 10° 8° 10° 10° Ok Angle measuring

Machine
5.57 5.62 5.53 5.58 5.68 Ok Height Measuring
Size Machine
48/78/73 Ok

35/80/96 Ok

✓ ✓ ✓ ✓ ✓ Ok
Inspection
Record ✓ ✓ ✓ ✓ ✓ Ok
Appearance

✓ ✓ ✓ ✓ ✓ Ok
Ok
Structure/
✓ ✓ ✓ ✓ ✓ Ok
Assembly
✓ ✓ ✓ ✓ ✓ Ok
Ok
✓ ✓ ✓ ✓ ✓ Ok
✓ ✓ ✓ ✓ ✓ Ok
Function ✓ ✓ ✓ ✓ ✓ Ok

✓ ✓ ✓ ✓ ✓ Ok
Reliability

Continuous Top1
Improvement Top2
Remark
Inspector: Is mass production Engineering Technology:
Final Result ☑ Passed Production
at same time? Quality Approval:
Verdict ☐Unqualified Confirmation: ☑Yes ☐no

1. All items must be checked continuously for atleast 5 pieces.

Precautions 2. The reliability testing items for the first inspection are only experiments that can yield conclusions in a short
period of time (such as firing tests, tensile/recoil tests, etc.).
3. The top defective items in process quality statistics should be continuously followed up for 2 batches.
1. When a new machine/line is started, the final inspection station on the production line should prepare 5 samples
Fill out and place them in the inspection area, notifying IPQC for inspection. After the inspection is deemed qualified,
instructions mass production can begin.
2. Scope of application: First piece inspection is required for new machine startup, line startup, mold repair/tool
adjustment, process parameter changes, material changes, etc.
3. Inspection results: Mark "✓" for qualified items, "X" for non-qualified items, and "/" for items not inspected. This
form will be retained for one year.
 Product Endoscopic Instruments Form Number BM/QP23-D/00
BM Medical Name
Ultrasonic Welding Inspection Operation Guide Inspection BM/SIP-GF-05 Total 1 Page First Page
Basis
Model Specification ENDO BLC L Batch 230504 – 15 Quality to be 301P25 Inspection Full
Number sent for Quantity Inspection
inspection
Serial Inspection Requirements Inspection Methods Appliances and Test Results Conclusion
Number enviroment
No Deformation, indentation, scratches, Check for the defects caused by the lack of OK
1 Appearance flash and other defects welding / OK

Uniform Welds Visual Inspection

Visual Inspection
Size Weld Width: 0.5± 0.3mm Measurement Caliper OK OK
2
Use a 50mm rubber hammer with a force of 50mm rubber OK OK
2kg, and quickly strike the weld seam of the hammer, Force
instrument at a distance of 300mm (at the Gauge, Measuring
Weld is Firm fastest speed usually achieved by a Tape
person). Observe that the instrument
should not show any visible cracks or
separations.
Strength Pry open the welded shell and observe that Caliper OK OK
No incomplete welding there should be no unwelded connection
3 areas exceeding 5mm along the weld
seam.

Inspection (Date): Review(Date): 24-05-2023 Approval(date):

24-05-2023
 BM Medical ELC Process Testing Records
Disposable Endoscopic stapler Model Specification
Product Name And components ELC L Batch Number 230504-15 2074

Testing Component Used (✓) Test Items

Serial
No. Instrument Smooth Weld Unusual Smooth Left Right
Number 6035R 4525R 4548R 6048R Rotation Seam Sound Insertion & Rotati- Rotati-
Removal on on
Appearance Result Remark

Note: 1. Staple diagram number,usually three types of curved stapler cartridges are used for testing.

2. When rotating left, test whether it is a dry fire; when rotating right, test for the same.

Inspection By: Date: 26-05-2023

 BM Medical ELC Process Testing Records
Disposable Endoscopic stapler Model Specification
Product Name And components ELC L Batch Number 230504-15 2074

Testing Component Used (✓) Test Items

Serial
No. Instrument Smooth Weld Unusual Smooth Left Right
Number 6035R 4525 4548R 6048 Rotation Seam Sound Insertion Rotati- Rotati-
R R & on on
Appearance Result Remark
Removal

Note: 1. Staple diagram number, usually three types of curved stapler cartridges are used for testing.

2. When rotating left, test whether it is a dry fire; when rotating right, test for the same.

Inspection By: Date: 26-05-2023

 Page 21
 BM Medical ELC Process Testing Records
Disposable Endoscopic stapler Model Specification
Product Name And components ELC L Batch Number 230504-15 2074

Testing Component Used (✓)

Test Items
Serial
No. Instrument Smooth Weld Unusual Smooth Left Right
Number 6035R 4525 4548R 6048 Rotation Seam Sound Insertion & Rotati- Rotati-
R R Removal on on
Appearance Result Remark

Note: 1. Staple diagram number, usually three types of curved stapler cartridges are used for testing.

2. When rotating left, test whether it is a dry fire; when rotating right, test for the same.

Inspection By: Date: 26-05-2023

 Page 22
 BM Medical ELC Process Testing Records
Disposable Endoscopic stapler Model Specification
230504-15
Product Name And components ELC L Batch Number 2074

Testing Component Used (✓) Test Items

Serial
No. Instrument Smooth Weld Unusual Smooth Left Right
Number 6035R 4525 4548R 6048R Rotation Seam Sound Insertion & Rotati- Rotati-
R Removal on on
Appearance Result Remark

Note: 1. Staple diagram number, usually three types of curved stapler cartridges are used for testing.

2. When rotating left, test whether it is a dry fire; when rotating right, test for the same.

Inspection By: Date: 29-05-2023

 Page 23
 BM Medical ELC Process Testing Records
Disposable Endoscopic stapler Model Specification
Product Name And components ELC L Batch Number 230504-15 2074

Testing Component Used (✓) Test Items

Serial
No. Instrument Smooth Weld Unusual Smooth Left Right
Number 6035R 4525 4548R 6048 Rotation Seam Sound Insertion & Rotati- Rotati-
R R Removal on on
Appearance Result Remark

Note: 1. Staple diagram number, usually three types of curved stapler cartridges are used for testing.

2. When rotating left, test whether it is a dry fire; when rotating right, test for the same.

Inspection By: Date: 29-05-2023

 Page 24
 BM Medical ELC Process Testing Records
Disposable Endoscopic stapler Model Specification
Product Name And components ELC L Batch Number 230504-15 2074

Testing Component Used (✓) Test Items

Serial
No. Instrument Smooth Weld Unusual Smooth Left Right
Number 6035 4525R 4548R 6048 Rotation Seam Sound Insertion & Rotati- Rotati-
R R Removal on on
Appearance Result Remark

Note: 1. Staple diagram number, usually three types of curved stapler cartridges are used for testing.

2. When rotating left, test whether it is a dry fire; when rotating right, test for the same.

Inspection By: Date: 29-05-2023

 Page 25
 BM Medical ELC Process Testing Records
Disposable Endoscopic stapler Model Specification
Product Name And components ELC L Batch Number 230504-15 2074

Testing Component Used (✓) Test Items

Serial
No. Instrument Smooth Weld Unusual Smooth Left Right
Number 6035R 4525 4548R 6048R Rotation Seam Sound Insertion & Rotati- Rotati-
R Removal on on
Appearance Result Remark

Note: 1. Staple diagram number, usually three types of curved stapler cartridges are used for testing.

2. When rotating left, test whether it is a dry fire; when rotating right, test for the same.

Inspection By: Date: 29-05-2023

 Page 26
 BM Medical ELC Process Testing Records
Disposable Endoscopic stapler Model Specification
Product Name And components ELC L Batch Number 230504-15 2074

Testing Component Used (✓) Test Items

Serial
No. Instrument Smooth Weld Unusual Smooth Left Right
Number 6035 4525R 4548 6048R Rotation Seam Sound Insertion & Rotati- Rotati-
R R Removal on on
Appearance Result Remark

Note: 1. Staple diagram number, usually three types of curved stapler cartridges are used for testing.

2. When rotating left, test whether it is a dry fire; when rotating right, test for the same.

Inspection By: Date: 29-05-2023

 Page 27
 BM Medical ELC Process Testing Records
Disposable Endoscopic stapler Model Specification
Product Name And components ELC L Batch Number 230504-15 2074

Testing Component Used (✓) Test Items

Serial
No. Instrument Smooth Weld Unusual Smooth Left Right
Number 6035 4525R 4548 6048R Rotation Seam Sound Insertion & Rotati- Rotati-
R R Removal on on
Appearance Result Remark

Note: 1. Staple diagram number, usually three types of curved stapler cartridges are used for testing.

2. When rotating left, test whether it is a dry fire; when rotating right, test for the same.

Inspection By: Date: 29-05-2023

 Page 28
 BM Medical ELC Process Testing Records
Disposable Endoscopic stapler Model Specification
Product Name And components ELC L Batch Number 230504-15 2074

Testing Component Used (✓) Test Items

Serial
No. Instrument Smooth Weld Unusual Smooth Left Right
Number 6035R 4525 4548R 6048R Rotation Seam Sound Insertion & Rotati- Rotati-
R Removal on on
Appearance Result Remark

Note: 1. Staple diagram number, usually three types of curved stapler cartridges are used for testing.

2. When rotating left, test whether it is a dry fire; when rotating right, test for the same.

Inspection By: Date: 29-05-2023

 Page 29
 BM Medical ELC Process Testing Records
Disposable Endoscopic stapler Model Specification
230504-15
Product Name And components ELC L Batch Number 2074

Testing Component Used (✓) Test Items

Serial
No. Instrument Smooth Weld Unusual Smooth Left Right
Number 6035R 4525 4548R 6048 Rotation Seam Sound Insertion & Rotati- Rotati-
R R Removal on on
Appearance Result Remark

Note: 1. Staple diagram number, usually three types of curved stapler cartridges are used for testing.

2. When rotating left, test whether it is a dry fire; when rotating right, test for the same.

Inspection By: Date: 29-05-2023

 Page 30
 BM Medical Numbering Table
BM/QP-SC-B07

Production Batch Number: 230504-15 Product Model: ENDO BLC L 2074

Number Number Number Number Number

Person/Date: /25-05-2023
 BM Medical Numbering Table
BM/QP-SC-B07

Production Batch Number: 230504-15 Product Model: ENDO BLC L 2074

Number Number Number Number Number

Person/Date: /25-05-2023

 Page 32
 BM Medical Numbering Table
BM/QP-SC-B07

Production Batch Number: 230504-15 Product Model: ENDO BLC L 2074

Number Number Number Number Number

Person/Date: /25-05-2023

 Page 33
 BM Medical Inspection Request Form
BM/QP23-F/00

Date of Inspection: 24-05-2023 Submitted By: Wang Jing

Process Name: Specification and Model: ENDO

BLC L

Production Batch Number: 230504-15 Quantity to be sent for inspection: 301

Inspection
Method: ☑Full Inspection Sampling Ratio:__________________

Judgement:

Remark:

Inspector/Date: 24-05-2023

BM Medical Inspection Request Form

BM/QP23-F/00

Date of Inspection: 25-05-2023 Submitted By:

Process Name: Specification and Model: ENDO

BLC L

Production Batch Number: 230504-15 Quantity to be sent for inspection: 301

Inspection Sampling Proportion:__________________

Method: ☑Full Inspection

Judgement:

Remark:

Inspector/Date: 25-05-2023

 Page 34
 BM Medical Inspection Request Form
BM/QP23-G/00

Submitted By: Date: 29-05-2023

Product Specification and ENDO BLC L

Name Model

Supplier Quantity 300 Batch Number 230504-15

Inspection
Date 29-05-2023 Inspection Inspection
Quantity Materials
Inspection
Conclusion Qualified

Remark: 2074

Inspector:

BM Medical Inspection Request Form

BM/QP23-F/00

2074

Date of Inspection: 29-05-2023 Submitted By:

Process Name: Specification and Model: ENDO

BLC L

Production Batch Number: 230504-15 Quantity to be sent for inspection: 301

Inspection
Method: ☐Full Inspection Sampling Ratio: 30%

Judgement:

Remark:

Inspector/Date: 29-05-2023

 Page 35
BM Medical

Clearance Record
Record No.: QR-21-013 (V1.1)

Product Name Instrument Specification and Model ENDO BLC L

Production 230504-15 Production Quantity Clearance 25-05-

Batch Number Date 2023

Project Operational Requirements Test Result

Materials Remaining material return and waste disposal ☑

Intermediate Count, place in prescribed location, comply with status signs ☑

Product

Waste Clean up the scene and place it at the specified location ☑

Materials

Tools and Clean and place in specified location ☑

Materials

Production Alcohol wipe, meets status mark ☑

Equipment,
Desktop

Sanitary Ware Clean it and place it in the specified place to dry ☑

Sweeper 25-05-2023

Inspector 25-05-2023

 Page 36
 Finished goods receipt
Storage Receipt Number: IF202305300001 Production batch number 230504-15 Warehouse: Finished Goods Warehouse Storage Category: Production Storage

Production Order Number: PA202305050002 Date of Entry: 30-05-2023 Storage Category: Production Storage Remark: 2074

Product Code Product Code Specification and Model Quantity Product category Production batch
number

C030030300 Single-use Endoscopic ENDO BLC L 301.00 Endoscopic 230504-15

Linear Cutting Stapler Stapler
and Components (Body) Product

Subtotal 301.00

Total 301.00

Prepared by: Reviewer Receiver

 BM Medical Record number: QR-09-058 (V1.0)

Shipment Inspection Report Customer Code:2074

Single-use Endoscopic Linear

Product name Cutting Stapler and Components Specification and Model ENDO BLC L Production 230504-15
(Body) Batch
Number

Production Date 20-05-2023 Validity Period Qualified

Quantity

Serial Project Inspection Requirements No. of Sample No. of Judgement

Number Qualified
Items

The seal of the double-layer PE bag should be intact 50 50 Qualified

without any channels, damage, or foreign objects.

Inner Packaging
1
The edges of the blister packaging should be smooth, 50 50 Qualified
without burns, rolled edges, channels, etc.

1. The packaging should be intact without

damage, with the product batch number and 50 50 Qualified
Outer Packaging expiration date correctly printed, and the
2 individual packaging should be arranged
Packaging neatly.
2. The instruction manual in the inner box should
be intact, with no missing pages.
3. The quantity of individual items in the inner box
should be correct, with no missing items.
4. The items in the inner box should be correctly
arranged, with no missing items.

Sterility performance (sterilized, if Should be sterile

3 requested by the customer).

E0Fresidue (if requested by the ≤10 µg/g (domestic) or ≤4 mg/item (international)

4 customer).

Review (Date): 20-05-2023

Inspector(Date): 20-04-2023

 Page 38
 BM Medical Technology Co., Ltd.
Product Release Form

Quality record number: QR-11-001 (V1.1). Customer Code:2074 No: 23112101

Single-use Endoscopic Linear

Product Name Production Batch 230504-15 Production Date 29-05-2023 Input Quantity 301 sets
Cutting Stapler and Number
Components (Body)
Specification ENDO BLC L Sterilization Batch Validity Period 28-05-2028 Release 300 sets
Number Quantity

Review Content

Result Remark
Review Items Standard (Complies ✓ Does not comply ×
Not applicable N/A)

✓
Production process Complies with process requirements, operations follow specific work instructions

✓
Production records Should be complete, accurate, standardized, and meet record-keeping requirements

✓
Process inspection Process quality sampling inspection is normal

✓
Cleaning management Cleaning meets regulation

N/A
Sterilization status Check sterilization certificate/E0 residue inspection report, no abnormalities

Finished product Inspections have been carried out according to the corresponding inspection guidelines, with no missing ✓
inspection items, and the results meet the requirements

✓
Inspection records Should be complete, accurate, standardized, and meet record-keeping requirements

✓
Deviation status ☑Not Have ☐Have, Factors that have a significant or potential impact on product
quality have been eliminated
✓
Others Whether other requirements under the order are meet

Review conclusion Reviewed by: Date: 21-11-2023

Release opinion Released by: Date: 21-11-2023

 Page 39