BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER MEDTECH AMERICA, INC.

    MDR report key: 17567058 · Received August 17, 2023

    Report

    Report Number
    1037955-2023-00028
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Report Date
    July 18, 2023
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    UDI-DI
    00810116022588
    PMA / PMN Number
    K021724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO UNIT WAS RETURNED TO DMTA WITHIN THE TIMEFRAME OF THIS INVESTIGATION. THE SUSPECT DEVICE WAS NOT INDICATED TO BE OBTAINABLE. IT IS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE OF THE COMPLAINT AS REPORTED WITHOUT ACCESS TO THE DEVICE IN QUESTION. IT IS ACKNOWLEDGED THERE COULD BE MANY ROOT CAUSES FOR THE COMPLAINT INFORMATION RECEIVED. IT IS ALSO 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

    DIODE LASER FIBER BURN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736594 DORNIER MEDTECH AMERICA, INC. DIODE LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. K2311580 C2322S 00810116022588

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male