MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number	030450
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2018
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 hepatectomy procedure, when using on a blood vessel, the first firing stopped midway.They replaced the reload and continued using the handle to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that the loading was partially fired with the interlock engaged.The jaws were open.Staple pushers were visible at the 2 cm cut line.Microscopic evaluation noted that the loading unit had damage to the cutting edge of the knife blade.Functionally the loading unit was loaded into a post market vigilance instrument, the interlock was over ridden, and the loading unit was applied to test media.All remaining staples were placed, and test media was cleanly transected.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 damaged knife blade may occur when an obstacle has been incorporated in the jaws during application.The information booklet which accompanies each product shipment cautions the user; ensure that no obstructions (such as clips) are incorporated in the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.The root cause of the observed damage was misuse of the product 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: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 8203333
• Report Number: 1219930-2018-06920
• Device Sequence Number: 18890572
• Product Code: GDW
• UDI-Device Identifier: 20884523002819
• UDI-Public: 20884523002819
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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: 02/28/2022
• Device Model Number: 030450
• Device Catalogue Number: 030450
• Device Lot Number: N7B0589KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1