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

Model Number	RELTACK4XDPT
Medical Device Problem Codes	Positioning Failure (1158); Device Difficult to Setup or Prepare (1487); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
According to the reporter, during a laparoscopic abdominal wall scar hernia repair, during mesh tacking, tacking was possible, however the tack stopped coming out from midway, and tacking could no longer be done.Even upon changing the cartridge, tacking was still not possible.It was difficult to load the reload onto the handle and difficult to operate the lock and unlock button.A new device was taken out and used to resolve the issue.There was no patient injury.

• Brand Name: RELIATACK
• Common Device Name: 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: 19790665
• Report Number: 1219930-2024-03238
• Device Sequence Number: 4134324
• Product Code: GDW
• UDI-Device Identifier: 10884521202429
• UDI-Public: 10884521202429
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: RELTACK4XDPT
• Device Catalogue Number: RELTACK4XDPT
• Device Lot Number: N4C2265Y
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/22/2024
• Date Device Manufactured: 03/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown