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

Model Number ABSTACK30

Device Problems Failure To Adhere Or Bond (1031); Torn Material (3024)

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

Event Date 02/22/2018

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 a laparoscopic ventral hernia repair, during insertion into patient, using the device to fixate mesh onto the abdominal wall, a hole was shot in the mesh, resulting in a tack in the abdominal wall but no fixation for the mesh.The tack from the device shot a hole in the mesh.The device remains implanted.No injury to the patient.Tacks were fired normally from the device.The surgeon managed to fixate the mesh after all.

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
• 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: 7362974
• MDR Text Key: 103266874
• Report Number: 1219930-2018-01598
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K071920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: ABSTACK30
• Device Catalogue Number: ABSTACK30
• Device Lot Number: N6B0897MX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2018
• Date Device Manufactured: 02/28/2016
• 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