BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSK-TC ELECTRODE

    MDR report key: 6901675 · Received September 28, 2017

    Report

    Report Number
    3006630150-2017-03829
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    September 5, 2017
    Report Date
    September 5, 2017
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250010114
    PMA / PMN Number
    K050084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: NA. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED: MODEL #: CSK-TC10 LOT #: 041217. DESCRIPTION: CSK TC ELECTRODE, 10CM TOTAL QUANTITY: 1.

    Description of Event or Problem · 1

    DEVICE ANALYSIS OF THE RETURNED ELECTRODES INDICATED THAT TRACES OF POTTING EPOXY WERE FOUND ON THE HUBS. THE EPOXY LEAKED THROUGH THE SHAFT OPENINGS IN IT'S LIQUID STATE DURING THE MANUFACTURING PROCESS, AND WAS NOT REMOVED AFTER CURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682078 CSK-TC ELECTRODE ELECTRODE GXI COSMAN MEDICAL CSK-TC15 080315 00813250010114

    Patients

    Seq Age Sex Outcome Treatment
    1