BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL TC ELECTRODE

    MDR report key: 6642273 · Received June 14, 2017

    Report

    Report Number
    3006630150-2017-02046
    Event Type
    Malfunction
    Date Received
    June 14, 2017
    Date of Event
    May 22, 2017
    Report Date
    May 22, 2017
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250013054
    PMA / PMN Number
    K050084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: TCN-10 LOT #: 021916, 013017, 121716 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: TCN-10 LOT #: 021916, 013017, 121716, 111516 AND 020416 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM DEVICE EVALUATION PERFORMED ON THE RETURNED ELECTRODES FOUND THAT ALL DEVICES EXHIBITED DISCOLORED EPOXY, CRACKS AND CHIP OUTS. THE ROOT CAUSE OF THIS FAILURE WAS DUE TO THERMAL STRESS ASSOCIATED WITH AUTOCLAVE CYCLES. 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT SEVERAL ELECTRODES HAVE PROBLEMS WHERE THE EPOXY IS CHIPPED AROUND THE HUB WHERE FLUID CAN SEEP IN.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT SEVERAL ELECTRODES HAVE PROBLEMS WHERE THE EPOXY IS CHIPPED AROUND THE HUB WHERE FLUID CAN SEEP IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422992 NITINOL TC ELECTRODE ELECTRODES GXI COSMAN MEDICAL TCN-10 020916 00813250013054

    Patients

    Seq Age Sex Outcome Treatment
    1