BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL TC ELECTRODE 10CM

    MDR report key: 7826838 · Received August 29, 2018

    Report

    Report Number
    3006630150-2018-02335
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    August 15, 2018
    Report Date
    August 29, 2018
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250013054
    PMA / PMN Number
    K050084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUAVE CLINIC 701 GOLF VIEW DRIVE MEDFORD OR 96080 UNITED STATES ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: TCN-10 SERIAL/LOT: (B)(4) DESCRIPTION: NITINOL TC ELECTRODE 10CM QUANTITY:1 MODEL: TCN-10 SERIAL/LOT: (B)(4) DESCRIPTION: NITINOL TC ELECTRODE 10CM 3M CABLE QUANTITY:1 MODEL: TCN-15 SERIAL/LOT: (B)(4) DESCRIPTION: NITINOL TC ELECTRODE 15CM QUANTITY:1.

    Description of Event or Problem · 1

    DEVICE EVALUATION PERFORMED ON THE RETURNED ELECTRODES TCN-10 (LOT 013017) AND TCN-10 (LOT 110916) SHOWED THAT THE EPOXY WAS DISCOLORED AND A CHIP OUT. 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. THIS FAILURE MECHANISM IS DUE TO EXTERNAL MECHANICAL FORCE AND THERMAL STRESS ASSOCIATED WITH MULTIPLE AUTOCLAVE CYCLES. EVALUATION OF TCN-15 (LOT 052715) REVEALED A CHIP OUT. THIS FAILURE MECHANISM IS DUE TO EXTERNAL MECHANICAL FORCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668308 NITINOL TC ELECTRODE 10CM PROBE, RADIOFREQUENCY LESION GXI COSMAN MEDICAL TCN-10 013017 00813250013054

    Patients

    Seq Age Sex Outcome Treatment
    1