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

Model Number ABSTACK30

Device Problems Loss of or Failure to Bond (1068); Failure to Advance (2524)

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

Event Date 02/05/2019

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 hernia procedure when the device was being applied during fixation, the device fired for the first 5 tacks and then it stopped.It was also noted that some of the tacks fell down after firing.Another device was opened to complete the case.

• 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: 8381690
• MDR Text Key: 137522520
• Report Number: 1219930-2019-01225
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884523006520
• UDI-Public: 10884523006520
• Combination Product (y/n): N
• Reporter Country Code: KU
• PMA/PMN Number: K071920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2019

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
• Device Lot Number: N8A1152MX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 03/01/2019
• 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