BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3420061 · Received August 13, 2013

    Report

    Report Number
    3420061
    Event Type
    Malfunction
    Date Received
    August 13, 2013
    Date of Event
    July 24, 2013
    Report Date
    August 13, 2013
    Manufacturer
    BIOLITEC MEDICAL DEVICES INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    DURING A LASER LITHOTRIPSY CASE, A LASER FIBER WAS OPENED ONTO THE STERILE FIELD. THE FIBER WAS CONNECTED TO THE LASER MACHINE AND THE AIMING BEAM WAS SET TO TWO BARS AND NO BEAM WAS SEEN ON THE END OF THE FIBER. THE AIMING BEAM WAS PLACED AT THREE BARS (THE MAXIMUM) AND STILL NO AIMING BEAM ON THE SCREEN AND THE FIBER WOULD NOT DELIVER ANY ENERGY. A DIFFERENT FIBER WAS OPENED AND IT WORKED AS EXPECTED (BEAM SEEN WHEN SET TO TWO BARS AND ENERGY DELIVERED WHEN LASER FIRING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388776 * POWERED LASER SURGICAL GEX BIOLITEC MEDICAL DEVICES INC. 101140 A13-0174-B

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR