BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TC ELECTRODE

    MDR report key: 7440994 · Received April 18, 2018

    Report

    Report Number
    3006630150-2018-01400
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    December 20, 2017
    Report Date
    April 18, 2018
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250013054
    PMA / PMN Number
    K060799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: NA /ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED/ MODEL #: CSK-TC10/ LOT #: K510/ DESCRIPTION: CSK TC ELECTRODE, 10CM TOTAL QUANTITY: 1 MODEL #: CSK-TC10 LOT #: L467 DESCRIPTION: CSK TC ELECTRODE, 10CM TOTAL QUANTITY: 1 MODEL #: TCN-10 LOT #: 011617 DESCRIPTION: NITINOL TC ELECTRODE, 100 MM TOTAL QUANTITY: 4.

    Description of Event or Problem · 1

    DEVICE EVALUATION WAS PERFORMED ON THE RETURNED PRODUCTS. CSK-TC10 ELECTRODES WITH LOT NUMBERS K510 AND L467 WAS FOUND TO HAVE THE HUB COMPLETELY SEPARATED FROM THE SHAFT DUE TO EXCESSIVE MECHANICAL FORCE. TCN-10 ELECTRODES WITH LOT # 011617 (TOTAL QUANTITY 4) HAD REVEALED THERE WAS DISCOLORATION (BROWN/AMBER) IN THE EPOXY WITH CHIP OUTS. THE DISCOLORED EPOXY OF ALL FOUR ELECTRODES IS UNRELATED TO THE REPORTED COMPLAINT AND IS DUE TO EXTERNAL MECHANICAL FORCE AND THERMAL STRESS ASSOCIATED WITH MULTIPLE AUTOCLAVE CYCLES. TCN-10 ELECTRODE WITH LOT # 111516 WAS FOUND TO HAVE DISCOLORED EPOXY DUE TO EXTERNAL MECHANICAL FORCE AND THERMAL STRESS ASSOCIATED WITH MULTIPLE AUTOCLAVE CYCLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282474 TC ELECTRODE PROBE, RADIOFREQUENCY LESION GXI COSMAN MEDICAL TCN-10 111516 00813250013054

    Patients

    Seq Age Sex Outcome Treatment
    1