BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEI ULTRA MD 60

    MDR report key: 3264803 · Received July 26, 2013

    Report

    Report Number
    3264803
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    July 25, 2013
    Report Date
    July 26, 2013
    Manufacturer
    LASER ENGINEERING, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING LASER IN THE PATIENT'S ESOPHAGUS AND FELT SOMETHING GO WRONG; PULLED OUT LASER. LASER TECHNICIAN TOOK THE LASER OUT OF THE ROOM INTO THE HALL, WHERE IT STARTED TO SMOKE AND SMELL AS IF IT WERE ON FIRE. SPRAYED FIRE EXTINGUISHER INTO VENTS. NO HARM TO THE PATIENT OR TO THE STAFF.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350172 LEI ULTRA MD 60 POWERED LASER SURGICAL INSTRUMENT GEX LASER ENGINEERING, INC. 60L *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR