BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER DIODE LASER FIBER

    MDR report key: 12450571 · Received September 9, 2021

    Report

    Report Number
    1037955-2021-00044
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Report Date
    August 12, 2021
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K110364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO MANUFACTURING DEFECTS WERE REVEALED IN THE EVALUATION OF THE RETURNED FIBER UNITS. IT IS ACKNOWLEDGED ALL FIBERS ARE 100% POWER TESTED PRIOR TO RELEASE WHICH CONFIRMS THE OPERATIONAL CAPACITY OF THE FIBERS. ADDITIONALLY, THE UNITS ARE 100% VISUALLY INSPECTED FOR DEFECTS. THE ROOT CAUSE OF THE COMPLAINT AS REPORTED WAS NOT ABLE TO BE CONFIRMED, HOWEVER, IT IS LIKELY TO RELATE TO THE APPLICATION OR METHOD OF THE DEVICE. DORNIER FIBERS ARE FRAGILE AND MUST BE HANDLED WITH INCREASED CARE DURING HANDLING AS INSTRUCTED ON THE DORNIER DIODE IFU QSF-881. DORNIER WILL CONTINUE TO MONITOR COMPLAINTS RELATED TO THIS REPORT. NO TRENDS, DEVIATIONS, OR DEFECTS WERE IDENTIFIED.

    Description of Event or Problem · 1

    A NOTIFICATION WAS RECEIVED REGARDING DIODE FIBER UNITS WHICH WERE REPORTED TO HAVE BURNED DURING USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345804 DORNIER DIODE LASER FIBER DIODE LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. K2308084, K2312393 C4320S, C0621S, C3920S

    Patients

    Seq Age Sex Outcome Treatment
    1