BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL TC ELECTRODE

    MDR report key: 7531900 · Received May 22, 2018

    Report

    Report Number
    3006630150-2018-01781
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    May 8, 2018
    Report Date
    May 21, 2018
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250013054
    PMA / PMN Number
    K50084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: NA. A TOTAL OF (5) ELECTRODES WERE ANALYZED: TCN-10, LOT 011116, QUANTITY (1), NITINOL TC ELECTRODE, 100 MM THE DEVICE ANALYSIS PERFORMED ON THE (1) ELECTRODE REVEALED DISCOLORED EPOXY 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 UNRELATED TO THE REPORTED COMPLAINT AND IS DUE TO EXTERNAL MECHANICAL FORCE AND THERMAL STRESS ASSOCIATED WITH MULTIPLE AUTOCLAVE CYCLES. TCN-15 LOT 051016, QUANTITY (3) NITINOL TC ELECTRODE, 150 MM THE DEVICE ANALYSIS PERFORMED ON THE (3) ELECTRODES REVEALED DISCOLORED EPOXY 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 UNRELATED TO THE REPORTED COMPLAINT AND IS DUE TO EXTERNAL MECHANICAL FORCE AND THERMAL STRESS ASSOCIATED WITH MULTIPLE AUTOCLAVE CYCLES. CSK-TC10, LOT N184, QUANTITY (1) CSK TC ELECTRODE, 10CM THE DEVICE ANALYSIS PERFORMED ON THE (1) ELECTRODE WAS FOUND TO BE COMPLETELY SEPARATED FROM THE HUB DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE. THE SHAFT WAS NOT RETURNED FOR ANALYSIS. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE SEPARATED SHAFT.

    Description of Event or Problem · 1

    THE DEVICE ANALYSIS PERFORMED ON THE FIVE ELECTRODES REVEALED THAT FOUR OF THEM HAD DISCOLORED EPOXY 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 UNRELATED TO THE REPORTED COMPLAINT AND IS DUE TO EXTERNAL MECHANICAL FORCE AND THERMAL STRESS ASSOCIATED WITH MULTIPLE AUTOCLAVE CYCLES. THE DEVICE ANALYSIS PERFORMED ON THE FIFTH ELECTRODE WAS FOUND TO BE COMPLETELY SEPARATED FROM THE HUB DUE TO EXCESSIVE EXTERNAL MECHANICAL FORCE. THE SHAFT WAS NOT RETURNED FOR ANALYSIS. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE SEPARATED SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375929 NITINOL TC ELECTRODE PROBE, RADIOFREQUENCY LESION GXI COSMAN MEDICAL TCN-10 011116 00813250013054

    Patients

    Seq Age Sex Outcome Treatment
    1