BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARVAC 90 WITH INTEGRATED CABLE

    MDR report key: 3001032 · Received February 27, 2013

    Report

    Report Number
    3006524618-2013-00088
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIRTY MINUTES INTO A PROCEDURE USING THE AMBIENT MEGAVAC 90 WAND, THE WAND GAVE AN ERROR MESSAGE. A STARVAC 90 WAND WAS OPENED AND THAT WAND ALSO GAVE AN ERROR MESSAGE. THE PROCEDURE WAS ULTIMATELY COMPLETED USING A COMPETITOR'S PRODUCT. THERE WERE NO OTHER DELAYS OR PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83640 STARVAC 90 WITH INTEGRATED CABLE ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other