BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL TC ELECTRODE

    MDR report key: 6723524 · Received July 18, 2017

    Report

    Report Number
    3006630150-2017-02379
    Event Type
    Malfunction
    Date Received
    July 18, 2017
    Date of Event
    May 12, 2017
    Report Date
    May 12, 2017
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250013054
    PMA / PMN Number
    K050084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS: MODEL #: TCN-10 LOT#: 111215 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM.

    Description of Event or Problem · 1

    DEVICE ANALYSIS OF TWO RETURNED ELECTRODES REVEALED ISSUES WITH THE EPOXY WITHIN THE HUB. ELECTRODE LOT # 120715 DEVICE ANALYSIS REVEALED THAT THE EPOXY HAD A CHIP AT THE HUB, A CRACK IN THE EPOXY AND THE EPOXY WAS BLACK. THERE WERE ALSO CRACKS AT THE ELECTRODE SHAFT. DEVICE ANALYSIS FOR ELECTRODE LOT # 111215 REVEALED THAT THE EPOXY HAD A CHIP AT THE HUB, MANY CRACKS AND THE EPOXY WAS BLACK. THERE WERE ALSO CRACKS AT THE ELECTRODE SHAFT. THE COLOR OF NEWLY CURED EPOXY IS AMBER, LIGHT BROWN. IF THE EPOXY IS SUBJECTED TO TOO MANY AUTOCLAVE CYCLES IT BECOMES BRITTLE AND DISCOLORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502362 NITINOL TC ELECTRODE ELECTRODES GXI COSMAN MEDICAL TCN-10 120715 00813250013054

    Patients

    Seq Age Sex Outcome Treatment
    1