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

Model Number ABSTACK15

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 01/22/2019

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 inguinal hernia repair, when the surgeon was trying to apply the absorbable tacks to secure the mesh laparoscopically, the mesh tacker broke so it could not fire tacks.

• Brand Name: ABSORBATACK
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8424474
• MDR Text Key: 138921825
• Report Number: 1219930-2019-01556
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523006506
• UDI-Public: 10884523006506
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/15/2019

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: 05/31/2021
• Device Model Number: ABSTACK15
• Device Catalogue Number: ABSTACK15
• Device Lot Number: N8E0575MX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/15/2019
• Date Device Manufactured: 05/15/2018
• 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