BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIMLINE

    MDR report key: 1531547 · Received November 4, 2009

    Report

    Report Number
    1531547
    Event Type
    Malfunction
    Date Received
    November 4, 2009
    Date of Event
    November 3, 2009
    Report Date
    November 4, 2009
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    SURGEONS REQUESTED 200 MICRON LASER FIBER. SLIMLINE 200 FIBER DELIVERY DEVICE WAS OPENED. SURGEON BEGAN USING THE FIBER BUT COMPLAINED THAT IT IS NOT WORKING. IT MADE A CLICKING SOUND WHICH IS DIFFERENT THAN THE USUAL SOUND WHEN PEDAL PRESSED. SURGEONS REQUESTED ANOTHER FIBER; NEW FIBER WORKED.

    Description of Event or Problem · 1

    SURGEONS REQUESTED 200 MICRON LASER FIBER. SLIMLINE 200 FIBER DELIVERY DEVICE WAS OPENED. SURGEON BEGAN USING THE FIBER BUT COMPLAINED THAT IT IS NOT WORKING. IT MADE A CLICKING SOUND WHICH IS DIFFERENT THAN THE USUAL SOUND WHEN PEDAL PRESSED. SURGEONS REQUESTED ANOTHER FIBER; NEW FIBER WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIMLINE LASER FIBER, HOLMIUM GEX LUMENIS, INC. * 80770908

    Patients

    Seq Age Sex Outcome Treatment
    1 *