BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMBIENT HIPVAC 50 WAND WITH INTEGRATED FINGER

    MDR report key: 2950518 · Received February 5, 2013

    Report

    Report Number
    3006524618-2013-00056
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE USING THE AMBIENT HIPVAC 50 WAND IFS, A PIECE OF THE BLACK SHEATHING FLAKED OFF INSIDE OF THE SURGICAL SITE. THE SURGEON WAS CONFIDENT THAT ALL DEBRIS WAS RETRIEVED, AND WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT SIGNIFICANT DELAY. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47811 AMBIENT HIPVAC 50 WAND WITH INTEGRATED FINGER ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND GEI ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other