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

Model Number SIGTRSB60AMT

Device Problems Misfire (2532); Separation Failure (2547)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during laparoscopic sleeve gastrectomy procedure, on the third firing of stapler, the jaws of the device lock on tissue and it did not cut at distal end.Manual cut was done to release from the device and suture at distal end.

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 procedure, on the third firing of stapler, the device did not cut at distal end.Manual cut was done to release from the device and suture at distal end.No patient injury.

Manufacturer Narrative

This event has been reassessed and found to be a non-mdr reportable complaint.The issue being reported is not associated with a serious injury or potential for serious injury with reoccurrence.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 reload was partially fired with the interlock engaged.The jaws were open.Staple pushers were visible at the 0.25cm 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.Once the reload was fully fired, the trs suture 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 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.The root cause of the observed damage was found to be due to the device not being used as intended which caused or contributed to the reported condition.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: 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: 8288461
• MDR Text Key: 134454652
• Report Number: 1219930-2019-00576
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521717626
• UDI-Public: 10884521717626
• Combination Product (y/n): N
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: SIGTRSB60AMT
• Device Catalogue Number: SIGTRSB60AMT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: 01/29/2019; 02/27/2019; 09/17/2019
• Supplement Dates FDA Received: 02/25/2019; 03/22/2019; 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR