BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL TC ELECTRODE

    MDR report key: 6911523 · Received October 3, 2017

    Report

    Report Number
    3006630150-2017-03442
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 14, 2017
    Report Date
    September 14, 2017
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250017502
    PMA / PMN Number
    K050084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL #: TCN-10-3M LOT #: 090116 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM, WITH 3M CABLE TOTAL QUANTITY: 2; MODEL #: TCN-10-3M LOT #: 031017 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM, WITH 3M CABLE TOTAL QUANTITY: 1; MODEL #: TCN-10-3M LOT #: 101716 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM, WITH 3M CABLE TOTAL QUANTITY: 1.

    Description of Event or Problem · 1

    DEVICE EVALUATION PERFORMED ON THE RETURNED ELECTRODES SHOWED THAT THE EPOXY HAD A CHIP OUT AND DISCOLORATION WAS NOTED. 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
    692094 NITINOL TC ELECTRODE ELECTRODES GXI COSMAN MEDICAL TCN-10-3M 090116 00813250017502

    Patients

    Seq Age Sex Outcome Treatment
    1