MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RELOAD THICK TISSUE; STAPLE, IMPLANTABLE

Catalog Number	TRT10
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # p56484.Date of event: month and day unknown; only year (2018) is known.Device evaluation: the analysis results found that the trt10 cartridge reload was received with the reload forks damaged, fully loaded with staples, and the swing tab was noted to be broken, making the reload nonfunctional.No functional test could be performed due the condition of the reload.While no conclusion could be reached as to how the damage to the device occurred, it is possible that the damaged was due to an improper handling of the device.Please refer to the "instruction for use" for more information.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Event or Problem Description
It was reported that during an unknown procedure, when the surgeon tried to fire the device, the knife did not go forward.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: 7804315
• Report Number: 3005075853-2018-12270
• Device Sequence Number: 19199719
• Product Code: GDW
• UDI-Device Identifier: 20705036003233
• UDI-Public: 20705036003233
• 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
• Report Date (Section B): 05/27/2018

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: 03/31/2022
• Device Catalogue Number: TRT10
• Device Lot Number: P4RD4H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1