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

Model Number	EGIATRS45AMT
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2018
Type of Reportable Event	Malfunction
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 1cm cut line.The distal suture on the anvil side was still anchored.Functionally the reload was loaded into a post market vigilance instrument, the interlock was over ridden, and the reload was applied to test media.All remaining staples were placed, and test media was cleanly transected.The distal suture was properly released.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 unreleased sutures may occur if the firing sequence is not completed.In this situation, the internal hinges which release the sutures may not engage fully and reinforcement material may not deploy properly.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.No relationship between the device and the reported incident was confirmed.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter: occurred during a colectomy functional end to end anastomosis procedure.For the second firing, at the closure of the insertion, the surgeon fully squeezed the handle.However, the anchoring suture at the tip was not removed.The device was removed from the tissue by force but no tissue damage was caused.There was no patient harm.The status of the patient is reported as no problem.

• Brand Name: ENDO GIA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven 06473
• MDR Report Key: 7473561
• Report Number: 1219930-2018-02360
• Device Sequence Number: 1608005
• Product Code: GDW
• UDI-Device Identifier: 20884521190884
• UDI-Public: 20884521190884
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133938
• 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
• Report Date (Section B): 04/30/2018

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
• Operator of Device: Health Professional
• Device Model Number: EGIATRS45AMT
• Device Catalogue Number: EGIATRS45AMT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2018
• Initial Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1