BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROCARE SYSTEM 2000

    MDR report key: 1151347 · Received September 9, 2008

    Report

    Report Number
    2951580-2008-00066
    Event Type
    Injury
    Date Received
    September 9, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 5, 2008
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K020832
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE INVESTIGATION HAS BEEN COMPLETED. THREE DEVICES, TURBOVAC 90 WITH INTEGRATED CABLE ARTHROWAND, SYSTEM 2000 CONTROLLER, AND ARTHROCARE FOOT CONTROL, WERE USED IN THE SAME PROCEDURE. THE TURBOVAC 90 WITH INTEGRATED CABLE WILL BE FILED UNDER MDR 2951580-2008-00065 AND THE ARTHROCARE FOOT CONTROL WILL BE FILED UNDER MDR 2951580-2008-00070.

    Description of Event or Problem · 1

    IN 2008, A CLINICAL INCIDENT INVOLVING A TURBOVAC 90 WITH INTEGRATED CABLE ARTHROWAND, SYSTEM 2000 CONTROLLER, AND ARTHROCARE FOOT CONTROL WAS REPORTED TO ARTRHOCARE CORPORATION. THE REPORTED INCIDENT INVOLVED A KNEE ARTHROSCOPY PROCEDURE IN WHICH THE PATIENT SUSTAINED A FIRST DEGREE BURN LOCATED AT POINT OF ENTRY AT THE PORTAL. THE BURN WAS TREATED WITH GAUZE AND DRY BANDAGES. IT WAS ALSO REPORTED THE PHYSICIAN FELT A SHOCK FROM THE FOOTPEDAL AND THE WAND BECAME VERY HOT DURING THE PROCEDURE. IN ADDITION, IT WAS REPORTED THE SUCTION LINE OF THE ARTHROWAND WAS NOT CONNECTED TO HOSPITAL VACUUM EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROCARE SYSTEM 2000 ELECTROSURGICAL CUTTING & COAGULATION DEVICE GEI ARTHROCARE CORP. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other