BEUDAMED
    FDA Adverse Event Other Summary report: N

    ULTRAVAC 90 WITH INTEGRATED CABLE

    MDR report key: 2223820 · Received August 18, 2011

    Report

    Report Number
    2951580-2011-00096
    Event Type
    Other
    Date Received
    August 18, 2011
    Date of Event
    July 7, 2011
    Report Date
    August 18, 2011
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K083306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT'S AGE WAS REQUESTED, BUT TO DATE HAS NOT BEEN PROVIDED. THE DEVICE WAS REPORTED AS RETURNING FOR INVESTIGATION. TO DATE THE DEVICE HAS NOT BEEN RETURNED. ONCE THE DEVICE HAS BEEN RETURNED, A COMPLETE INVESTIGATION WILL BE PERFORMED AND A F/U REPORT WILL BE PROVIDED WITH ADD'L INFO. THE SECOND DEVICE USED IN THE SAME PROCEDURE IS REPORTED UNDER MEDWATCH NUMBER 2951580-2011-00095.

    Description of Event or Problem · 1

    DURING A SHOULDER ARTHROSCOPY PROCEDURE USING TWO ULTRAVAC 90 WITH INTEGRATED CABLE ARTHROWANDS, THE TIP OF THE WAND REPORTEDLY STARTED SPARK AND MELT ONE MIN AFTER THE SURGEON STARTED USING THEM. IT IS UNK IF ANY FRAGMENTS FELL INTO THE PT. THE PROCEDURE WAS REPORTED AS COMPLETED WITH NO ADVERSE REACTIONS TO THE PT AND NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAVAC 90 WITH INTEGRATED CABLE ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION JG34300-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other