BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL TC ELECTRODE

    MDR report key: 6788910 · Received August 11, 2017

    Report

    Report Number
    3006630150-2017-02839
    Event Type
    Malfunction
    Date Received
    August 11, 2017
    Date of Event
    May 5, 2017
    Report Date
    May 5, 2017
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250013061
    PMA / PMN Number
    K050084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: NA. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL: TCN-15 LOT: 090613 DESCRIPTION: NITINOL TC ELECTRODE, 150 MM QUANTITY: 3 MODEL: TCN-15 LOT: 091614 DESCRIPTION: NITINOL TC ELECTRODE, 150 MM QUANTITY: 1.

    Description of Event or Problem · 1

    DEVICE ANALYSIS PERFORMED ON ALL THE RETURNED ELECTRODES SHOWED THAT THE EPOXY WAS CHIPPED OUT AND DISCOLORED DUE TO THERMAL STRESS ASSOCIATED WITH AUTOCLAVE CYCLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569445 NITINOL TC ELECTRODE ELECTRODES GXI COSMAN MEDICAL TCN-15 090613 00813250013061

    Patients

    Seq Age Sex Outcome Treatment
    1