BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER TURBOVAC 90 WITH INTEGRATED CABLE

    MDR report key: 2011821 · Received February 24, 2011

    Report

    Report Number
    2951580-2011-00024
    Event Type
    Other
    Date Received
    February 24, 2011
    Date of Event
    December 1, 2010
    Report Date
    February 24, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. IT WAS ALSO REPORTED THE PHYSICIAN USED ABLATION SET POINT 6 AND 5 WHICH IS NOT RECOMMENDED FOR THE DEVICE AND IS LOWER THAN THE DEFAULT ABLATION SET POINT. THE INSTRUCTIONS FOR USE FOR THE DEVICE HAS THE FOLLOWING WARNING: CAUTION: USING A SET POINT LOWER THAN THE DEFAULT SET POINT FOR THE WAND MAY RESULT IN THERMAL INJURY TO THE PHYSICIAN OR PT. A LOT HISTORY RECORD REVIEW WAS PERFORMED. NO ABNORMALITIES WERE FOUND IN THE LOT HISTORY RECORD REVIEW. THE LOT MET ALL DEVICE SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING A SHOULDER ARTHROSCOPY PROCEDURE USING A SUPER TURBOVAC 90 WITH INTEGRATED CABLE ARTHROWAND, THE PT SUSTAINED A FIRST DEGREE BURN DESCRIBED AS THE SIZE OF APPROXIMATELY ONE INCH. THE PT WAS PRESCRIBED ANTIBIOTICS AND THE BURN WAS REPORTED AS HEALING ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER TURBOVAC 90 WITH INTEGRATED CABLE ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP. EZ08500-C

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other