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

Model Number ABSTACK15

Device Problems Failure to Advance (2524); Material Twisted/Bent (2981); Firing Problem (4011)

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

Event Date 04/02/2018

Event Type  malfunction  

Manufacturer Narrative

Health professional (hpro).Post market vigilance (pmv) led an evaluation of one photograph of one device.Photographic inspection noted the shaft was broken.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of these conditions may occur if the instrument is applied with excessive force or side load, causing excess torque on the rotating helices and tube shaft which can cause poor tack penetration.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic totally extraperitoneal (tep) herioplasty, when the surgeon was trying to use the device to fix the mesh, the shaft of the device was bent and was unable to fire any tacks.They used a new device to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one photograph and one device.Photographic and visual inspection noted the shaft was broken.Visual inspection noted a tack was visible in the shaft.Functionally, the handle could be actuated.The remaining tacks deployed and seated properly in the test media.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related condition.Replication of these conditions may occur if the instrument is applied with excessive force or side load, causing excess torque on the rotating helices and tube shaft which can cause poor tack penetration.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: ABSORBATACK
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 7721886
• MDR Text Key: 115281133
• Report Number: 1219930-2018-04084
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523006506
• UDI-Public: 10884523006506
• Combination Product (y/n): N
• PMA/PMN Number: K071920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

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 Expiration Date: 07/31/2020
• Device Model Number: ABSTACK15
• Device Catalogue Number: ABSTACK15
• Device Lot Number: N7G0787MX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 08/29/2018; 08/08/2018
• Supplement Dates FDA Received: 09/18/2018; 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR