BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAVAC WITH INTEGRATED CABLE

    MDR report key: 3193157 · Received June 25, 2013

    Report

    Report Number
    3006524618-2013-00241
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 27, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE USING THE ULTRAVAC ICW WAND, THE WAND STOPPED WORKING AFTER 10 MINUTES OF ACTIVATION AND GAVE AN ERROR MESSAGE. THE PROCEDURE WAS ULTIMATELY COMPLETED USING A COMPETITOR'S DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289004 ULTRAVAC WITH INTEGRATED CABLE ELECTRODE, ELECTROSURGICAL, ACTIVE, FOOT GEI ARTHROCARE CORPORATION JG33600-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other