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

Model Number EGIATRS60AMT

Device Problem Separation Failure (2547)

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

Event Date 01/23/2017

Event Type  malfunction  

Manufacturer Narrative

This event was previously reported to the fda on a summary report and is now being submitted on a 3500a per fda request.Post market vigilance (pmv) led an evaluation of four endo gia* tri-staple rr 60mm m/t reload.The event report alleges the product was used in a surgical procedure.The visual inspection of the returned product noted the first three reloads were partially fired with the interlock engaged.The fourth reload was fully fired.The jaws were open.Staple pushers were visible at the 4 cm cut line indicating the point where the handle compression had stopped for the first three, and the front sutures were intact with pieces of the reinforcement material was left attached.Pmv performed functional testing which included the reloads were loaded into a post market vigilance instrument (0155) for functional testing.The interlock was overridden and the reloads were then applied to test media.All remaining staples were placed and test media was cleanly transected.The reloads¿ interlock was tested and found to function properly.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture.Replication of the partial fire condition with interlock engagement may occur when the firing handle has not been completely cycled.If the instrument return knobs are retracted at any point once the firing cycle has begun, the loading unit will engage into safety interlock and prevent further attempts to fire by ceasing the placement of staples and tissue transection, and prevent patient harm.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.The file will be closed as a misuse of the product.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

Event Description

According to the reporter: during an open lung resection, the healthcare provider had to cut the tread that was holding the reinforced material on the zulu with a scissor.There was no injury to the patient.

• Brand Name: ENDO GIA
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 7084279
• MDR Text Key: 93815722
• Report Number: 1219930-2017-09415
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521191013
• UDI-Public: 10884521191013
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K133938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2017

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 Expiration Date: 09/30/2019
• Device Model Number: EGIATRS60AMT
• Device Catalogue Number: EGIATRS60AMT
• Device Lot Number: N6J0413KX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Initial Date Manufacturer Received: 03/29/2017
• Initial Date FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1