BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER TURBOVAC WITH INTEGRATED CABLE

    MDR report key: 1070741 · Received July 2, 2008

    Report

    Report Number
    2951580-2008-00048
    Event Type
    Other
    Date Received
    July 2, 2008
    Date of Event
    May 28, 2008
    Report Date
    July 1, 2008
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K072865
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE WAND IS NOT AVAILABLE FOR INVESTIGATION AND THE LOT NUMBER WAS NOT KNOWN, THEREFORE, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. IT WAS REPORTED THE PATIENT'S BURN RESULTED FROM THE SALINE DRIPPING ONTO THE PATIENT'S ARM. THE INSTRUCTIONS FOR USE INSTRUCTS THE USER TO ATTACH THE SUCTION LINE TO HOSP VACUUM EQUIPMENT AND WARNS THE USER THAT FAILURE TO ATTACH THE SUCTION ADAPTER CAN RESULT IN THERMAL INJURY TO PHYSICIAN OR PT.

    Description of Event or Problem · 1

    IN 2008, A CLINICAL INCIDENT INVOLVING A SUPER TURBOVAC ARTHROWAND AND WAS REPORTED TO ARTHROCARE CORPORATION. DURING A SHOULDER ARTHROSCOPY PROCEDURE, A PT SUSTAINED A THIRD DEGREE BURN REPORTED AS 1" X 4" IN SIZE. THE BURN WAS TREATED WITH AN ANTIBIOTIC OINTMENT AND DRESSINGS. IT WAS REPORTED THE SALINE WAS DRIPPING OUT OF THE SUCTION TUBING THAT WAS NOT HOOKED UP DURING THE SHOULDER ARTHROSCOPY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER TURBOVAC WITH INTEGRATED CABLE ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other