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

Catalog Number	TL90
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Batch # p56c8p.Device evaluation summary: the analysis results showed that the tl90 device arrived with no apparent damage and with a trh90 partially loaded on the device.The reload was returned fully loaded with staples and damage was noted at the distal end.In addition, two reloads (tr90, tlh90) were received.The reloads (b, c) were received fully fired.The device was tested for functionality with a test reload and it cycled, fired, and all the staples formed as intended.The device fired without any difficulties and the staples were noted to have the proper b-formed shape.It should be noted that the reload will only fit and operate properly in the linear stapler for which it has been designed that is the tl90 device will only work with a tr90 reload and a tlh90 device will work with the trh90 reload.For more information please refer to the instructions for use.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.
Event or Problem Description
It was reported that during an unknown procedure, the reload would not fit.The stapler wouldn't fire.Case completed with another device of the same product code.There were no patient consequences reported.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8833600
• Report Number: 3005075853-2019-20819
• Device Sequence Number: 2390223
• Product Code: GDW
• UDI-Device Identifier: 10705036013198
• UDI-Public: 10705036013198
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2019

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: 03/21/2022
• Device Catalogue Number: TL90
• Device Lot Number: P92A7J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/26/2019
• Patient Sequence Number: 1