BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER MEDTECH AMERICA, INC.

    MDR report key: 17789317 · Received September 21, 2023

    Report

    Report Number
    1037955-2023-00034
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Report Date
    September 21, 2023
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K121938
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE RETURNED FOR EVALUATION WAS ANALYZED AND IT WAS DETERMINED NO MANUFACTURING DEFECTS WERE PRESENT. THE DEVICE WAS CONFIRMED WITH NO RECORDED USAGE ON THE RFID TAG, WHICH WAS NOT CONSISTENT WITH INFORMATION RECEIVED FROM THE COMPLAINANT THAT THE FIBER EMITTED SMOKE DURING USAGE. ALL LASER FIBERS MANUFACTURED BY DORNIER MEDTECH AMERICA ARE SUBJECT TO 100% INSPECTION FOR VISUAL DEFECTS AS WELL AS POWER PERFORMANCE TESTING WHICH CONFIRMS THE DEVICE IS OPERATING AS INTENDED. THE ROOT CAUSE FOR THE COMPLAINT AS REPORTED WAS NOT POSSIBLE TO CONFIRM, HOWEVER, IT IS RECOGNIZED IT WAS NOT DUE TO MANUFACTURING DEFECT OR DEVICE INADEQUACY.

    Description of Event or Problem · 0

    HOLMIUM FIBER REPORTEDLY EMITTED SMOKE/BURNED DURING USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2036411 DORNIER MEDTECH AMERICA, INC. HOLMIUM LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. K2013161 F3122S

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown