BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT SUPER MULTIVAC 50 WITH INTEGRATED FING

    MDR report key: 3963439 · Received June 20, 2014

    Report

    Report Number
    3006524618-2014-00162
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KNEE PROCEDURE USING AN AMBIENT SUPER MULTIVAC 50 IFS WAND, THE WAND DISPLAYED AN ERROR MESSAGE UPON CONNECTION. THE SURGEON OPTED TO COMPLETE THE PROCEDURE USING A COMPETITIVE 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
    363412 AMBIENT SUPER MULTIVAC 50 WITH INTEGRATED FING ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND GEI ARTHROCARE CORPORATION 1054493

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other