MAUDE Adverse Event Report: COVIDIEN SURGICAL RELIATACK; STAPLE, IMPLANTABLE

Model Number	RELTACK5RDPT
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: reltack4xdpt, reltack4xdpt reliatack device 4 deeppurc (lot# n5a1787y); reltack5rdpt, reload reltack5rdpt reliatack 5deeppurc (lot# n3f0419y); reltack5r, reltack5r reliatack articulating reloada (lot# n4d2268y); reltack5r, reltack5r reliatack articulating reloada (lot# n4d2268y).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 incisional hernia repair, when fixing the mesh, when the cartridge was being installed, it could not be locked and fixed.The shaft was straight and vertical, but it was not fixed.After several attempts, it was fixed, and it was used on the patient.The issue occurred on the other two devices.A different type of tacker was used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
Additional information: g3, h6.Additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.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
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22666278
• Report Number: 1219930-2025-03372
• Device Sequence Number: 7486714
• Product Code: GDW
• UDI-Device Identifier: 20884521202402
• UDI-Public: (01)20884521202402(17)260531(10)N3F0419Y
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 08/14/2025

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 Expiration Date: 05/31/2026
• Device Model Number: RELTACK5RDPT
• Device Catalogue Number: RELTACK5RDPT
• Device Lot Number: N3F0419Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/14/2025
• Date Device Manufactured: 06/19/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11.
• Patient Sex: Unknown