BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER DIODE LASER FIBER

    MDR report key: 8750531 · Received July 1, 2019

    Report

    Report Number
    1037955-2019-00025
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Report Date
    June 7, 2019
    Manufacturer
    DORNIER MEDTECH LASER GMBH
    Product Code
    GEX
    PMA / PMN Number
    K083500
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE VISUAL EXAMINATION, THE FIBER BREAKS OBSERVED WERE LIKELY CAUSED BY MECHANICAL FORCE DUE TO USER MISHANDLING. AFTER THE FIBERS WERE RE-STRIPPED, THEY WERE TESTED ON A DIODE LASER WITH 100% LASER ENERGY TRANSMISSION EFFICIENCY. THE FACT THAT THE FIBER WAS ABLE TO BE USED FOR SOME AMOUNT OF TIME INDICATES THAT THE FIBER WAS FULLY CAPABLE OF FUNCTIONING AS INTENDED. IT IS HIGHLY UNLIKELY THAT THERE WERE ANY MANUFACTURING FAULTS WITH THIS FIBER. DORNIER FIBERS MUST BE HANDLED CAREFULLY BY THE USER AT ALL TIMES. DORNIER MEDTECH AMERICA, INC. (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF DORNIER MEDTECH LASER GMBH (THE MANUFACTURER) PER EXEMPTION NUMBER E2012001.

    Description of Event or Problem · 0

    CUSTOMER HAD TWO DIODE REUSABLE FIBERS, ONE USED AND ONE NEW, THAT BOTH SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544902 DORNIER DIODE LASER FIBER DIODE LASER FIBER GEX DORNIER MEDTECH LASER GMBH 400 MICRON REUSABLE DIODE FIBER

    Patients

    Seq Age Sex Outcome Treatment
    1