BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRAVAC 90 WITH INTEGRATED CABLE

    MDR report key: 1914420 · Received November 19, 2010

    Report

    Report Number
    2951580-2010-00106
    Event Type
    Other
    Date Received
    November 19, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 19, 2010
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPORTED AS RETURNING FOR INVESTIGATION. ONCE THE DEVICE HAS BEEN RETURNED, A COMPLETE INVESTIGATION WILL BE PERFORMED AND PROVIDED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    DURING A SHOULDER DECOMPRESSION ARTHROSCOPY PROCEDURE USING ULTRAVAC 90 WITH INTEGRATED CABLE ARTHROWAND, THE TIP OF THE WAND HAS REPORTEDLY MELTED AND THE WAND EMITTED SPARKS WHILE IN THE PT'S JOINT. THERE WAS NO REPORTED PT INJURY OR ADVERSE EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAVAC 90 WITH INTEGRATED CABLE ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION JG12000-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other