BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROCARE SUPER TURBOVAC 90

    MDR report key: 1963002 · Received January 13, 2011

    Report

    Report Number
    1963002
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 13, 2011
    Manufacturer
    ASCENT HEALTHCARE SOLUTIONS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING THE PERFORMANCE OF A RIGHT KNEE ARTHROSCOPY WITH REMOVAL OF LOOSE BODY, AN ARTHROCARE SUPER TURBOVAC 90 (WHICH WAS REFURBISHED BY ASCENT HEALTHCARE SOLUTIONS) WAS USED. DURING ITS USE, THE BLACK SHEATH THAT COVERS THE WAND BEGAN TO MIGRATE OVER THE TIP OF THE WAND. THE ENERGY THAT IS EMITTED FROM THE END OF THIS WAND BEGAN TO MELT THE SHEATH. THE WAND WAS REMOVED FROM OPERATION AND A NEW ONE WAS OPENED AND THE CASE COMPLETED.REPROCESSOR WAS CONTACTED AND REPRESENTATIVE WAS AWARE OF 3 OTHER INSTANCES WITH OTHER LOTS.======================HEALTH PROFESSIONAL'S IMPRESSION======================THE BLACK PLASTIC SHEATH COVERING THE LENGTH OF THE DEVICE MOVED TOWARD THE TIP OF THE DEVICE. THE BLACK SHEATH THAT COVERED THE TIP AND WAS "MELTED" AT THE TIP.WILL RETURN TO ASCENT HEALTHCARE SOLUTIONS (REPROCESSOR)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROCARE SUPER TURBOVAC 90 RF WAND GEI ASCENT HEALTHCARE SOLUTIONS * 1269084

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR NO OTHER THERAPIES