BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLMD DIAL LASER

    MDR report key: 5179890 · Received October 27, 2015

    Report

    Report Number
    5179890
    Event Type
    Malfunction
    Date Received
    October 27, 2015
    Date of Event
    September 24, 2015
    Report Date
    September 30, 2015
    Manufacturer
    PHOTOMEDEX, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CERVICAL HARDWARE REMOVAL CASE - ALL THE SCREWS HAD BEEN REMOVED FROM THE PLATE AND THE SURGEON WAS WORKING ON REMOVING THE PLATE WHEN THE LASER FLASHED A "SYSTEM FAILURE" AND "LAMP FAILURE" MESSAGE. TRIED TO RESET LASER BUT UNABLE TO DO SO. ALL CHARTABLE INFORMATION WAS GONE. THE SURGEON REMOVED PLATE AND LASER WAS NO LONGER NEEDED. TO BIOMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711081 CLMD DIAL LASER POWERED LASER SURGICAL INSTRUMENT GEX PHOTOMEDEX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR