BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUOTOME SIDELITE

    MDR report key: 1740278 · Received June 25, 2010

    Report

    Report Number
    1740278
    Event Type
    Malfunction
    Date Received
    June 25, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 25, 2010
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    UROLOGIST SURGEON INSERTED A SIDELITE LASER FIBER FOR TURP. ON THE FIRST OR SECOND FIRING, THE TIP OF THE LASER FIBER BROKE OFF. THE SURGEON RETRIEVED THE FIBER TIP AND THE FIBER WAS REPLACED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUOTOME SIDELITE LASER FIBER GEX LUMENIS, INC. 840-846 05161209

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR