BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPER TURBOVAC 90 WITH INTEGRATED CABLE

    MDR report key: 1884150 · Received October 14, 2010

    Report

    Report Number
    2951580-2010-00098
    Event Type
    Other
    Date Received
    October 14, 2010
    Date of Event
    July 28, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT AGE WAS REQUESTED FROM THE USER FACILITY. NO ADDITIONAL INFO HAS BEEN RECEIVED TO DATE. THE DEVICE WAS DISCARDED BY THE USER FACILITY. SINCE THE DEVICE WAS DISCARDED AND THE LOT NUMBER WAS NOT PROVIDED FOR THIS REPORT, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. NO CONCLUSION CAN BE MADE.

    Description of Event or Problem · 1

    DURING AN ANKLE ARTHROSCOPY PROCEDURE USING A SUPER TURBOVAC 90 WITH INTEGRATED CABLE ARTHROWAND, THE PT SUSTAINED CARTILAGE DAMAGE. THE PT HAS NOT RECEIVED TREATMENT FOR THE CARTILAGE DAMAGE. THE FACILITY REPORTED THE CAUSE OF THE CARTILAGE DAMAGE TO THE PT WAS NOT KNOWN.

    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.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other