MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITAN HEAVY WIRE; STAPLE, IMPLANTABLE

Catalog Number	TLH90
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Batch #m53h2z.Device evaluation summary: the analysis results showed that the tlh90 device arrived with no apparent damage with a reload loaded on the device.The reload was returned void of staples.The device was tested for functionality with a test reload and it cycled, fired, and all the staples formed as intended.The staple line was complete and the staples meet the staple form release criteria.The event described could not be confirmed as the device performed without any difficulties noted.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.The following information was requested, but unavailable: just for clarification, this device (tlh90) only delivers a staple line.A cut line must be manually done.Did the surgeon fire the device and no staples were delivered? or were staples seen in the surgical area but not in the tissue?.
Event or Problem Description
It was reported that during an open colectomy the device cut but didn't staple.The doctor hand sewed the colon.A second device was not used in the procedure.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: 9369157
• Report Number: 3005075853-2019-23748
• Device Sequence Number: 19698259
• Product Code: GDW
• UDI-Device Identifier: 10705036013242
• UDI-Public: 10705036013242
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/04/2019

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: 03/28/2020
• Device Catalogue Number: TLH90
• Device Lot Number: M9184P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1