BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOLMIUM - LIGHTGUIDE

    MDR report key: 501170 · Received October 27, 2003

    Report

    Report Number
    501170
    Event Type
    Other
    Date Received
    October 27, 2003
    Date of Event
    September 1, 2003
    Report Date
    September 1, 2003
    Manufacturer
    DORNIER MEDTECH AMERICA, INC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TIP OF HOLMIUM LASER FIBER BROKE OFF INSIDE PT. THEY ARE ALMOST CERTAIN THAT THE PIECE WASN'T RETRIEVED. IT IS ONLY 1MM IN SIZE AND THE DR FELT IT WOULD WASH OUT NATURALLY. THE PROCEDURE WAS THOUGHT TO BE SOME KIND OF URETHRA EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLMIUM - LIGHTGUIDE OTHER GEX DORNIER MEDTECH AMERICA, INC HF0200DSSM-02 A 2403-29S

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other