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

Model Number 030451

Device Problems Failure to Advance (2524); Failure to Fire (2610)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, for the first firing in lobectomy procedure, at vessel resection, the nurse connected the reload to the handle and the surgeon start squeezing it however the knife could not advance.They replaced it with new reload and the firing was successful.The following firings with the same handle were also successful.There was no patient injury.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that the loading unit was pre-fired with the interlock engaged.The jaws were open.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 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 pre-fire condition with interlock engagement may occur if the instrument firing handle had been partially compressed and released after pressing the green firing button.In this situation, the safety interlock feature will engage and prevent the reload from firing a second time.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7731819
• MDR Text Key: 115571344
• Report Number: 1219930-2018-04156
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523002829
• UDI-Public: 10884523002829
• Combination Product (y/n): N
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2018

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
• Device Operator: Health Professional
• Device Model Number: 030451
• Device Catalogue Number: 030451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Manufacturer Received: 07/13/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 10/04/2018
• Supplement Dates FDA Received: 10/02/2018; 10/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1