BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATLAS CONTROLLER

    MDR report key: 972098 · Received December 28, 2007

    Report

    Report Number
    2951580-2007-00095
    Event Type
    Other
    Date Received
    December 28, 2007
    Date of Event
    October 23, 2007
    Report Date
    December 21, 2007
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K040338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT RETURNED FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RETURNED FOR INVESTIGATION. TWO DEVICES, SUPER TURBOVAC WITH INTEGRATED CABLE (CATALOG NO. ASC4250-01) AND ATLAS SYSTEM CONTROLLER (CATALOG NO. H3500-00), WERE USED IN THE SAME PROCEDURE AND TWO SEPARATE MDRS ARE FILED FOR EACH DEVICE UNDER MEDWATCH NUMBERS 2951580-2007-00094 AND 2951580-2007-00095.

    Description of Event or Problem · 1

    IN 2007, A CLINICAL INCIDENT INVOLVING A SUPER TURBOVAC ARTHROWAND AND AN ATLAS CONTROLLER WAS REPORTED TO ARTHROCARE CORPORATION. DURING AN ARTHROSCOPIC PROCEDURE OF THE KNEE, THE PT SUSTAINED A BURN/BLISTER TO PT'S ANKLE (APPROXIMATELY 20 CM BY 1 TO 2 CM). THE BURN WAS TREATED WITH A BANDAGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other