BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER MEDTECH AMERICA, INC.

    MDR report key: 17789797 · Received September 21, 2023

    Report

    Report Number
    1037955-2023-00035
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Report Date
    September 21, 2023
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K021724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES RETURNED WERE EVALUATED AND WERE NOT DETERMINED TO HAVE EVIDENCE OF BURNING AS DESCRIBED BY THE COMPLAINANT. THE DEVICES WERE NOT CONFIRMED WITH ANY MANUFACTURING DEFECTS OR INADEQUACIES. IT IS ACKNOWLEDGED THAT ALL LASER FIBERS MANUFACTURED BY DMTA ARE 100% INSPECTED FOR POWER PERFORMANCE DEFECTS, OBJECTIVELY PROVIDING CONFIRMATION THE FIBERS ARE OPERATING AS INTENDED PRIOR TO DISTRIBUTION. NO TREND FOR COMPLAINTS RELATED TO THIS MATTER IS CURRENTLY OBSERVED. DORNIER WILL CONTINUE TO MONITOR COMPLAINTS RELATED TO THIS REPORT.

    Description of Event or Problem · 0

    TWO DIODE LASER FIBER BURNS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586065 DORNIER MEDTECH AMERICA, INC. DIODE LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. K2308084 C4322S

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown