BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NITINOL TC ELECTRODE

    MDR report key: 6815423 · Received August 23, 2017

    Report

    Report Number
    3006630150-2017-03071
    Event Type
    Malfunction
    Date Received
    August 23, 2017
    Date of Event
    August 1, 2017
    Report Date
    August 1, 2017
    Manufacturer
    COSMAN MEDICAL
    Product Code
    GXI
    UDI-DI
    00813250010107
    PMA / PMN Number
    K050084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: NA MODEL #: CSK-TC10 LOT # K237 DESCRIPTION: CSK TC ELECTRODE, 10CM QUANTITY: 1 MODEL #: CSK-TC10 LOT # K509 DESCRIPTION: CSK TC ELECTRODE, 10CM QUANTITY: 7 MODEL #: CSK-TC10 LOT # K239 DESCRIPTION: CSK TC ELECTRODE, 10CM QUANTITY: 4 MODEL #: CSK-TC10 LOT # L225 DESCRIPTION: CSK TC ELECTRODE, 10CM QUANTITY: 1 MODEL #: CSK-TC15 LOT # K240 DESCRIPTION: CSK TC ELECTRODE, 15 CM QUANTITY: 1 MODEL #: CSK-TC15 LOT #: 022317 DESCRIPTION: CSK TC ELECTRODE, 15 CM QUANTITY: 1 MODEL #: CSK-TC5 LOT # 031017 DESCRIPTION: CSK TC ELECTRODE, 5 CM QUANTITY: 1.

    Additional Manufacturer Narrative · 1

    MODEL #: CSK-TC10 LOT # K237 ¿ QUANTITY 1 LOT # K509 ¿ QUANTITY 10 LOT # K239 ¿ QUANTITY 7 LOT # L225 ¿ QUANTITY 1 DESCRIPTION: CSK TC ELECTRODE, 10CM MODEL #: CSK-TC15 LOT # K240 ¿ QUANTITY 2 LOT #: 022317 ¿ QUANTITY 1 DESCRIPTION: CSK TC ELECTRODE, 15 CM MODEL #: CSK-TC5 LOT # 03102017 ¿ QUANTITY 1 DESCRIPTION: CSK TC ELECTRODE, 5 CM THE TWENTY-THREE RETURNED ELECTRODES WERE ANALYZED AND EXTERNAL VISUAL INSPECTION REVEALED TRACES OF POTTING EPOXY ON ALL THE HUBS. THE EPOXY LEAKED THROUGH THE SHAFT OPENING IN ITS LIQUID STATE DURING THE MANUFACTURING PROCESS, AND WAS NOT REMOVED AFTER CURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER THE ELECTRODES WERE CLEANED AND STERILIZED, IT WAS NOTED THAT THE CABLES HAD MELTED EPOXY THAT WAS BUBBLING OUT FROM THE BASE OF THE NEEDLES.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT AFTER THE ELECTRODES WERE CLEANED AND STERILIZED, IT WAS NOTED THAT THE CABLES HAD MELTED EPOXY THAT WAS BUBBLING OUT FROM THE BASE OF THE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592941 NITINOL TC ELECTRODE ELECTRODE GXI COSMAN MEDICAL CSK-TC10 L225 00813250010107

    Patients

    Seq Age Sex Outcome Treatment
    1