BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER HOLMIUM LASER FIBER

    MDR report key: 6004923 · Received October 6, 2016

    Report

    Report Number
    1037955-2016-00040
    Event Type
    Malfunction
    Date Received
    October 6, 2016
    Date of Event
    August 14, 2016
    Report Date
    September 26, 2016
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K121938
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER PRODUCT EVALUATION, IT WAS DETERMINED THAT THE FIBER WAS LIKELY BROKEN DUE TO USER MISHANDLING AS THERE WAS NO EVIDENCE OF CHARRING AT ANY OF THE BREAK POINTS IN THE FIBER WHICH INDICATES THAT THE FIBER WAS BROKEN WHEN NO LASER ENERGY WAS BEING TRANSMITTED THROUGH THE FIBER. IT IS LIKELY THAT THE USER PUSHED THE FIBER INTO A SCOPE WHERE A SCOPE BEND OR BLOCKAGE PREVENTED THE FIBER FROM BEING PUSHED ANY FURTHER RESULTING THE BREAK BETWEEN PIECE A AND PIECE B. THE SUCCESSFUL TESTING OF THE FIBER AFTER REPROCESSING AND THE PRESENCE OF A PILOT BEAM WITH SUCCESSFUL LASER TRANSMISSION INDICATES THAT THE FIBER WAS FULLY CAPABLE OF FUNCTIONING AS INTENDED. IT IS LIKELY THAT THE FIBER BREAK WAS CAUSED BY THE END USER.

    Description of Event or Problem · 1

    "HLFDBX0270C SINGLE USE (OUT-OF-BOX) FAILURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658007 DORNIER HOLMIUM LASER FIBER HOLMIUM FIBER GEX DORNIER MEDTECH AMERICA, INC. 270 SINGLE-USE HOLMIUM FIBER F1516S

    Patients

    Seq Age Sex Outcome Treatment
    1