BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR RETURN ELECTRODE CABLE

    MDR report key: 3892285 · Received June 24, 2014

    Report

    Report Number
    0001811755-2014-02256
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 1, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    GXI
    PMA / PMN Number
    K032406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPON VISUAL INSPECTION, THE INTERNAL WIRES CLOSE TO THE LEMO ASSEMBLY WERE FOUND TO BE DAMAGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE MONOPOLAR RETURN ELECTRODE CABLE WAS READING HIGH IMPEDANCE, WHICH CAUSED A ONE HOUR DELAY. IT WAS REPORTED THAT THE PATIENT WAS SEDATED WHEN THE REPORTED EVENT OCCURRED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY UTILIZING BACK-UP EQUIPMENT. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE MONOPOLAR RETURN ELECTRODE CABLE WAS READING HIGH IMPEDANCE, WHICH CAUSED A ONE HOUR DELAY. IT WAS REPORTED THAT THE PATIENT WAS SEDATED WHEN THE REPORTED EVENT OCCURRED. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY UTILIZING BACK-UP EQUIPMENT. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369055 MONOPOLAR RETURN ELECTRODE CABLE PROBE, RADIOFREQUENCY LESION GXI STRYKER INSTRUMENTS-KALAMAZOO 14013

    Patients

    Seq Age Sex Outcome Treatment
    1