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

Model Number RELTACK3X10SW

Device Problems Component or Accessory Incompatibility (2897); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/06/2024

Event Type  malfunction  

Event Description

According to the reporter, during laparoscopic incisional hernia repair procedure, while loading the device for mix fixation, the device was unable to load.The issue occurred in 5 devices.The surgeon did not use the devices on the patient.A new tacker was opened and used to resolve the issue.This led to more than 30 minutes extended surgical time.

Manufacturer Narrative

D10 concomitant product: reltack3x10sw reliatack device w 30 std (lot#: n3f0649y); reltack3x10sw reliatack device w 30 std (lot#: n3f0649y); reltack3x10sw reliatack device w 30 std (lot#: n3f0649y); reltack3x10sw reliatack device w 30 std (lot#: n3f0649y).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: RELIATACK
• 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19027289
• MDR Text Key: 339232290
• Report Number: 1219930-2024-01413
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 10884521726376
• UDI-Public: 10884521726376
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2024

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: RELTACK3X10SW
• Device Catalogue Number: RELTACK3X10SW
• Device Lot Number: N3F0649Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 04/02/2024
• Date Device Manufactured: 05/15/2023
• 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
• Treatment: SEE NOTE ON H11.