BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMBIENT SUPER TURBOVAC 90 WITH INTEGRATED FING

    MDR report key: 3950599 · Received July 11, 2014

    Report

    Report Number
    3006524618-2014-00209
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 13, 2014
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A SHOULDER PROCEDURE USING AN AMBIENT SUPER TURBOVAC 90 IFS WAND, UPON REMOVING THE DRAPES, IT WAS DISCOVERED THAT THE PATIENT HAS SUSTAINED A SMALL SUPERFICIAL BURN. THE BURN DID NOT REQUIRE ANY TREATMENT AND THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406898 AMBIENT SUPER TURBOVAC 90 WITH INTEGRATED FING ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND GEI ARTHROCARE CORPORATION 1062674

    Patients

    Seq Age Sex Outcome Treatment
    1 Other