BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIMLINE EZ SINGLE USE

    MDR report key: 1003886 · Received November 30, 2007

    Report

    Report Number
    2914019-2007-00060
    Event Type
    Malfunction
    Date Received
    November 30, 2007
    Date of Event
    September 4, 2007
    Report Date
    October 30, 2007
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS IS AWAITING FURTHER INFO FROM USER FACILITY. A F/U REPORT WILL BE ISSUED IF ADD'L INFO IS REC'D, OR IF THE DEVICES ARE REC'D FOR EVAL.

    Description of Event or Problem · 1

    "EVENT DESCRIPTION: THE SURGEON WAS INSERTING THE PROBE THROUGH AN ADAPTER. TWO FIBERS IN THE PROBE BROKE DURING INSERTION. NO HARM TO THE PT. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)". NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIMLINE EZ SINGLE USE LASER FIBER, HOLMIUM GEX LUMENIS, INC. 840-893 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *