MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN TRI-STAPLE 2.0; STAPLE, IMPLANTABLE

Model Number SIGTRS60AMT

Device Problems Entrapment of Device (1212); Separation Failure (2547); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during laparoscopic sleeve gastrectomy, while on stomach, the reinforced material was still not released from the reload and the knife did not cut it all the way through.The surgeon had to manually try to remove the reload and tissue with a laparoscopic scissor.There was no patient injury.

Manufacturer Narrative

Additional information: g4, h3, h6 h3 evaluation summary: post market vigilance (pmv) led a photographic evaluation of two photographs of a reinforced reload inside the patient cavity.A visual inspection of the returned photos noted that the reinforcement material can be seen transected.The cut edge of the reinforcement material was jagged.The distal suture could not be seen in the returned photos.The sled position could not be seen.The jaws of the reload can be seen as partially open.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.A definitive root cause could not be determined with regard to the reported condition.Without the physical product, a definitive root cause could not be identified.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRI-STAPLE 2.0
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 9716823
• MDR Text Key: 179727506
• Report Number: 1219930-2020-00753
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521543638
• UDI-Public: 10884521543638
• Combination Product (y/n): N
• PMA/PMN Number: K160176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

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: 05/31/2022
• Device Model Number: SIGTRS60AMT
• Device Catalogue Number: SIGTRS60AMT
• Device Lot Number: N9F0316Y
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1