MAUDE Adverse Event Report: US SURGICAL PUERTO RICO MULTIFIRE ENDO GIA; STAPLE, IMPLANTABLE

Model Number	030813
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during laparoscopic appendectomy, the staplers were deployed but there was no action of the knife.The surgeon noted that the device was given by the scrub nurse with the security already released resulted in misfiring and by manipulation a blockage of the stapler.The surgeon used scissors to cut the tissue and used manual stapler to resolve the issue in order to complete the case.No patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the instrument body displayed no abnormalities.The visual inspection of the cartridge of the single use loading unit (sulu) noted the sulu was partially applied with the interlock engaged.Functionally, the knife blade and cam bars were reset; the sulu was reloaded in to the instrument, and applied over the appropriate test media producing acceptable results.The knife cut the test media cleanly and completely and the remaining staple line was properly formed.In addition, the sulu loaded and unloaded repeatedly without difficulty.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.Replication of the observed condition may occur if the handle is not completely compressed during application.This partial firing causes the interlock to engage and if a second attempt is made to fire the sulu it will not fire.The instructions for use for this product states: failure to firmly squeeze the handle all the way may result in an incomplete staple formation, which may compromise the integrity of the staple line.The device staplers are equipped with a safety interlock which prevents the handle from being squeezed a second time.The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MULTIFIRE ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• MDR Report Key: 9419075
• Report Number: 2647580-2019-05924
• Device Sequence Number: 19445540
• Product Code: GDW
• UDI-Device Identifier: 10884523003796
• UDI-Public: 10884523003796
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K900129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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: 05/31/2024
• Device Model Number: 030813
• Device Catalogue Number: 030813
• Device Lot Number: P9F1274MY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1