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

Model Number	030811
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
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, on a laparoscopic appendectomy, at the start of the procedure, the device did not fire.Another device was used to complete the case.There was 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 noted the single use loading unit(sulu) was partially applied with the interlock engaged.Functionally, the knife blade and cam bars were reset.The instrument and sulu were applied to test media with acceptable results; the pushers advanced, the knife cut completely and cleanly and the remaining staple line was properly formed.Records from each manufacturing lot are thoroughly reviewed to ensure that products are 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 devices 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 indicated which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.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: 9180697
• Report Number: 2647580-2019-05103
• Device Sequence Number: 19486621
• Product Code: GDW
• UDI-Device Identifier: 10884523003789
• UDI-Public: 10884523003789
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K900129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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: 03/31/2024
• Device Model Number: 030811
• Device Catalogue Number: 030811
• Device Lot Number: P9D1492MY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1