BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATLAS SYSTEM

    MDR report key: 1006501 · Received March 3, 2008

    Report

    Report Number
    2951580-2008-00014
    Event Type
    Other
    Date Received
    March 3, 2008
    Date of Event
    January 17, 2008
    Report Date
    February 28, 2008
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K040338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR INVESTIGATION. AWAITING COMPLETION OF INVESTIGATION OF DEVICE. TWO DEVICES, ULTRAVAC WITH INTEGRATED CABLE ( CATALOG NO. ASC5000-01) AND ATLAS CONTROLLER (CATALOG NO. H3000-00), WERE USED IN THE SAME PROCEDURE AND TWO SEPARATE MDRS ARE FILED FOR EACH DEVICE UNDER MEDWATCH NUMBERS 2951580-2008-00012 AND 2951580-2007-00014.

    Description of Event or Problem · 1

    IN 2008, A CLINICAL INCIDENT INVOLVING A ULTRAVAC ARTHROWAND AND ATLAS CONTROLLER WAS REPORTED TO ARTHROCARE CORP. DURING A LEFT SHOULDER SUBACROMIAL DECOMPRESSION PROCEDURE, THE PT SUSTAINED A THIRD DEGREE BURN ( FULL THICKNESS LOSS WHICH DID NOT INVOLVE MUSCLE) APPROX THE SIZE OF A SILVER DOLLAR SURROUNDING THE PORTAL. PT WAS TREATED BY A PLASTIC SURGEON AND RECEIVED A FULL SKIN GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS SYSTEM ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other