MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITANIUM STAPLER; STAPLE, IMPLANTABLE

Catalog Number	TL60
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.
Event or Problem Description
It was reported that during a radical gastrectomy procedure, after fired, noted the staples were malformed.Changed to new one to complete the surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b )(4).Batch r57v36.Investigation summary: the analysis results showed that the tl60 device was received with the hook shroud opened by the seam and with a cartridge loaded on the device.The cartridge was returned fully loaded with staples.No functional test could be performed due to the condition of the device.The device was disassembled to verify the condition of the internal components and the device was noted to have the lockout slide tip and the adjusting knob damaged.The damage to the lockout slide tip is consistent with an excessive force applied to the rotating knob when trying to dial down a locked device, causing the damage to the lockout and the adjusting knob.It should be noted that the instrument has been designed with a lockout feature, which during the first application, prevents turning the adjusting knob unless the retaining pin is pushed completely forward.Please reference the instructions for use for additional information.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8613628
• Report Number: 3005075853-2019-19163
• Device Sequence Number: 2372445
• Product Code: GDW
• UDI-Device Identifier: 10705036013181
• UDI-Public: 10705036013181
• Combination Product (Y/N): N
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/16/2023
• Device Catalogue Number: TL60
• Device Lot Number: R40982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 06/20/2019
• Patient Sequence Number: 1