MAUDE Adverse Event Report: PERFUSION SYSTEMS TOURNIKWIK TOURNIQUET SET; CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	79011
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.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
Medtronic received information that prior to use of the tournikwik tourniquet sets, the customer reported that the snares have been coming packed in such a way that they are bent and crimped and have been described as unusable.The devices were replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the customer did not have the example from the hospital but the bent/crimped devices are still coming intermittently in the packs.The customer stated that it seemed like where the devices were positioned within the pack makes them vulnerable to being bent.When they are bent or crimped like the one in the picture they are unusable as a snare.The crimps were occurring in the shaft (red part) of the tournikwik.

• Brand Name: TOURNIKWIK TOURNIQUET SET
• Common Device Name: CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21513112
• Report Number: 2184009-2025-00387
• Device Sequence Number: 4400698
• Product Code: GDJ
• UDI-Device Identifier: 00613994576477
• UDI-Public: 00613994576477
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K855144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2025

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
• Device Expiration Date: 03/15/2026
• Device Model Number: 79011
• Device Catalogue Number: 79011
• Device Lot Number: 2023030738
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2023
• 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
• Patient Sex: Unknown