BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMENIS MOSES 120W LASER

    MDR report key: 8185471 · Received December 20, 2018

    Report

    Report Number
    MW5082318
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    December 6, 2018
    Report Date
    December 12, 2018
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LASER FIBER WAS PLUGGED INTO THE LUMENIS MOSES 120W LASER MACHINE. WHEN START WAS PRESSED, A SMALL FLAME TRAVELED DOWN THE FIBER TO THE MACHINE WHERE IT WENT OUT. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026111 LUMENIS MOSES 120W LASER LASER GEX LUMENIS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1