BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIM LINE EZ

    MDR report key: 1032575 · Received March 28, 2008

    Report

    Report Number
    1032575
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 28, 2008
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE LASER FIBER BROKE WHILE THE SURGEON WAS LASERING THE URETHRAL STONE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIM LINE EZ FIBER, LASER GEX LUMENIS, INC. * 63470907

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR