BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIMLINE EZTM

    MDR report key: 1728962 · Received June 11, 2010

    Report

    Report Number
    1728962
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    June 4, 2010
    Report Date
    June 11, 2010
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LASER WOULD NOT RECOGNIZE THE SLIMLINE FIBER DEVICE - CHANGED TO ANOTHER LIKE DEVICE FROM SAME LOT NUMBER WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIMLINE EZTM LASER FIBER, SINGLE USE GEX LUMENIS, INC. * 09590110
    2 LUMENIS POWERSUITE LASER, SURGICAL, HOLMIUM GEX LUMENIS, INC. LUMENIS POWERSUITE 20 W *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR