BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBIENT HIPVAC 50 WAND WITH INTEGRATED FINGER

    MDR report key: 4061175 · Received August 7, 2014

    Report

    Report Number
    3006524618-2014-00236
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    May 15, 2014
    Report Date
    July 8, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP PROCEDURE USING AN AMBIENT HIPVAC 50 IFS WAND, THE PT ALLEGEDLY SUSTAINED A BURN ON THE LEFT HIP. NO DETAILS WERE PROVIDED REGARDING THE SEVERITY OF THE BURN OR ANY TREATMENT ADMINISTERED. THE PROCEDURE WAS COMPLETED USING A COMPETITIVE DEVICE. THERE WERE NO SIGNIFICANT DELAYS OR FURTHER PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464160 AMBIENT HIPVAC 50 WAND WITH INTEGRATED FINGER ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND GEI ARTHROCARE CORPORATION ASHA4730-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other