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

Model Number ABSTACK30

Device Problems Failure to Advance (2524); Detachment of Device or Device Component (2907)

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

Event Date 02/06/2019

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 procedure, the fixation system failed at the time of fixing the mesh in the repair of the hernia.The tackers were stuck in the "bastago", they were removed from the cavity and when a shot was fired the surgeon noticed that they were stuck.After several shots the tackers left but they did not notice the mesh anymore.Another tacker was requested to complete the case.There was no patient injury.

• 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: 8387609
• MDR Text Key: 137733908
• Report Number: 1219930-2019-01265
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523006520
• UDI-Public: 10884523006520
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K071920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2019

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 Model Number: ABSTACK30
• Device Catalogue Number: ABSTACK30
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 03/04/2019
• 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