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	03/20/2020
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 a laparoscopic appendectomy, the device did not fire.A new device was used to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was returned for evaluation.Visual inspection noted the instrument body displayed no abnormalities while sulu (single use loading unit) was partially applied.Inspection under the microscope displayed nicks on the knife blade.Functionally, the returned device had damage to the cutting edge of the knife blade due to an obstruction during testing.It was reported that the device did not fire.An associated device issue was confirmed.The product analysis noted evidence that the device was not used as intended.This can occur if the instrument is applied over an obstruction.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: -when positioning the instrument on the application site ensure that no obstructions such as previously clips are incorporated into the instrument jaws.Firing over an obstruction may result in improperly formed staples.Improperly formed staples may result in leakage or disruption of the staple line.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: 9927752
• Report Number: 2647580-2020-01235
• Device Sequence Number: 11454165
• Product Code: GDW
• UDI-Device Identifier: 10884523003789
• UDI-Public: 10884523003789
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2020

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: 08/31/2024
• Device Model Number: 030811
• Device Catalogue Number: 030811
• Device Lot Number: P9J0179MY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 06/16/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 07/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1