BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT SUPER TURBOVAC 90 WITH INTEGRATED FING

    MDR report key: 3202024 · Received June 27, 2013

    Report

    Report Number
    3006524618-2013-00250
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE USING AN AMBIENT SUPER TURBOVAC 90 IFS WAND, UPON PLUG IN, THE WAND WOULD NOT ACTIVATE AND DISPLAYED AN ERROR CODE. TWO ADDITIONAL WANDS WERE TIRED, BOTH WITH THE SAME RESULT. 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
    293174 AMBIENT SUPER TURBOVAC 90 WITH INTEGRATED FING ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other