BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2113014 · Received June 1, 2011

    Report

    Report Number
    2113014
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BIOLITEC, 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 CYSTO CASE, THE HOLMIUM LASER FIBER THAT WAS BEING USED WAS BROKEN. THE GREEN LIGHT WOULDN'T COME ON AND NO AIMING BEAM. THE FIBER WAS REMOVED AND A NEW FIBER WAS GIVEN TO STERILE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * LASER FIBER GEX BIOLITEC, INC. 101130 A11-0155-A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR