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

Model Number	EGIA30AMT
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2019
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 gastrectomy, on stapler removal, three reloads cannot be articulated back to its original position after articulation so the stapler was not able to remove directly from the trocar.To resolve the issue, took the stapler out with the trocar.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 reload was partially fired with the interlock engaged.The jaws were open.Staple pushers were visible at the cut line.Microscopic evaluation noted that the reload had damage to the cutting edge of the knife blade.Functionally, the reload was loaded into a post market vigilance instrument, the interlock was overridden, and the reload was cycled without hesitation and 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.Additionally, the investigation detected a secondary condition of knife damage that has no relationship to the reported condition.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.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: 8693013
• Report Number: 1219930-2019-03432
• Device Sequence Number: 2354577
• Product Code: GDW
• UDI-Device Identifier: 10884523003062
• UDI-Public: 10884523003062
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2019

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 Model Number: EGIA30AMT
• Device Catalogue Number: EGIA30AMT
• Device Lot Number: N7L1121KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 08/02/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1