BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3229275 · Received June 26, 2013

    Report

    Report Number
    3229275
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 26, 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

    LASER FIBER WAS OPENED FOR LASER LITHOTRIPSY IN CYSTO ROOM. ONCE FIBER WAS CONNECTED TO LASER THERE WAS NO AIMING BEAM AND NO ENERGY WAS EMITTED FROM FIBER. LASER FIBER WAS REMOVED AND REPLACED WITH ANOTHER FIBER. SECOND FIBER WORKED APPROPRIATELY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289743 * POWERED LASER SURGICAL GEX BIOLITEC MEDICAL DEVICES INC. 101130 A13-0236B

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR