BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROCARE QUANTUM SYSTEM

    MDR report key: 1366346 · Received April 22, 2009

    Report

    Report Number
    2951580-2009-00021
    Event Type
    Injury
    Date Received
    April 22, 2009
    Date of Event
    March 19, 2009
    Report Date
    April 17, 2009
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K082666
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY HOSPITAL. ESTIMATED DATE OF EVENT PROVIDED BY ARTHROCARE. THE DEVICE WAS REPORTED AS RETURNING FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE DEVICE IS RETURNED FOR INVESTIGATION. TWO DEVICES, SUPER TURBOVAC WITH INTEGRATED CABLE ARTHROWAND AND QUANTUM CONTROLLER WERE USED IN THE SAME PROCEDURE. THE SUPER TURBOVAC WITH INTEGRATED CABLE WILL BE FILED UNDER MDR 2951580-2009-00020 AND THE ARTHROCARE QUANTUM CONTROLLER WILL BE FILED UNDER MDR 2951580-2009-00021.

    Description of Event or Problem · 1

    A CLINICAL INCIDENT INVOLVING A SUPER TURBOVAC WITH INTEGRATED CABLE ARTHROWAND AND QUANTUM CONTROLLER WAS REPORTED TO ARTHROCARE CORPORATION. THE REPORTED INCIDENT INVOLVED A SHOULDER ARTHROSCOPY PROCEDURE IN WHICH THE PATIENT SUSTAINED A BURN TO ONE FINGER RESULTING IN A BLISTER AND REDNESS ON A SECOND FINGER. THE PATIENT'S FINGERS WERE COVERED WITH ELASTIC BANDAGES DURING THE PROCEDURE. THE BURNS WERE TREATED WITH DRESSINGS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other