BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT SUPER MULTIVAC 50 WAND WITH INTEGRATED FING

    MDR report key: 2961196 · Received February 8, 2013

    Report

    Report Number
    3006524618-2013-00067
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE END OF A PROCEDURE USING THE AMBIENT SUPER MULTIVAC 50 WAND, IT WAS NOTICED THAT SOME OF THE METAL PIECES FROM THE DISTAL TIP OF THE WAND WERE MISSING. AS THE WAND WAS BEING REMOVED FROM THE PT, ANOTHER PIECE DETACHED FROM THE TIP. THE SURGEON WAS ABLE TO IMMEDIATELY REMOVE THIS DETACHED PIECE; HOWEVER, HE IS UNSURE IF THE INITIAL MISSING PIECES REMAINED IN THE PT. THERE WERE NO DELAYS AND NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54957 AMBIENT SUPER MULTIVAC 50 WAND WITH INTEGRATED FING ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND GEI ARTHROCARE CORPORATION FN19420-B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other