BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCDC SPINEWAND

    MDR report key: 3963443 · Received June 20, 2014

    Report

    Report Number
    3006524618-2014-00181
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K061259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SPINE PROCEDURE USING A PERCDC SPINEWAND, THE CONTROLLER AND ACCESSORIES COULD NOT DETECT THE WAND UPON CONNECTION, LEAVING THE DISPLAY SCREEN BLANK. THIS DEFICIENCY RESULTED IN A SURGICAL DELAY OF ONE HOUR WHILE ANOTHER PERCDC SPINEWAND WAS LOCATED SO AS TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363438 PERCDC SPINEWAND ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION 1045598

    Patients

    Seq Age Sex Outcome Treatment
    1 Other