BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOURNI-COT - SMALL

    MDR report key: 23952445 · Received January 2, 2026

    Report

    Report Number
    1832653-2026-00001
    Event Type
    Injury
    Date Received
    January 2, 2026
    Date of Event
    August 29, 2025
    Report Date
    January 2, 2026
    Manufacturer
    MAR-MED INC.
    Product Code
    GAX
    UDI-DI
    00855364004030
    PMA / PMN Number
    K853472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MAR-MED HAS REQUESTED ADDITIONAL INFORMATION FROM THE USER FACILITY REGARDING THEIR INVESTIGATION INTO THE ADVERSE EVENT. MAR-MED WILL CONDUCT AN INVESTIGATION INTO THE ROOT CAUSES BASED ON INFORMATION RECEIVED.

    Description of Event or Problem · 0

    PATIENT UNDERWENT A SURGICAL PROCEDURE. THE PROCEDURE REQUIRED THE USE OF A DIGITAL TOURNIQUET, WHICH IS REMOVED AT THE END OF THE OPERATION. THE PATIENT UNDERWENT THE PROCEDURE ON THE IDENTIFIED FINGER AS PLANNED WITH THE TOURNIQUET BEING UTILISED AS PER STANDARD PRACTICE. DURING THE PROCEDURE, THE SAFETY TAG WAS REMOVED FROM THE TOURNIQUET TO AID VISIBILITY. THE PROCEDURE WAS COMPLETED AND THE PATIENT DISCHARGED HOME. UPON REVIEW IN THE OUTPATIENTS DEPARTMENT SIX DAYS LATER, THE DIGITAL TOURNIQUET WAS NOTED TO HAVE BEEN LEFT IN-SITU CAUSING THE FINGER TO BECOME SIGNIFICANTLY DAMAGED. THIS LED TO THE DIGIT BEING AMPUTATED THAT AFTERNOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5497 TOURNI-COT - SMALL DIGIT TOURNIQUET GAX MAR-MED INC. TCS 00855364004030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability