BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER MEDTECH AMERICA, INC.

    MDR report key: 19822756 · Received July 24, 2024

    Report

    Report Number
    1037955-2024-00027
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Report Date
    July 24, 2024
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K121938
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES RETURNED FOR EVALUATION WERE REVIEWED AND IT WAS CONFIRMED THAT THE FIBERS WERE BROKEN AT THE PROXIMAL SMA CONNECTOR, LIKELY DUE TO BURN DAMAGE WHICH WAS ALSO OBSERVED. UPON REVIEW, THE LASER FIBERS DID NOT EXHIBIT ANY MANUFACTURING DEFECTS OR INCONSISTENCIES AND THE CUSTOMERS FEEDBACK REGARDING THE LASER FIBERS BEING DIFFICULT TO CONNECT TO A LASER DEVICE WAS NOT CONSISTENT WITH DORNIER INVESTIGATION FINDINGS AS THIS EXPERIENCE WAS NOT RECREATED. IT WAS NOTED UPON REVIEW OF THE RFID INFORMATION THAT THE LASER FIBERS WERE EACH UTILIZED BY THE CUSTOMER, WHICH PROVIDES OBJECTIVE EVIDENCE THE LASER FIBERS WERE AT LEAST OPERATING AS INTENDED PRIOR TO THE BREAKAGE AND BURN DAMAGE OBSERVED. IT IS RECOGNIZED THAT 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 WITHIN SPECIFICATION. IT IS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE OF THE BURN DAMAGE IDENTIFIED, HOWEVER, IT IS POSSIBLE TO STATE THIS DAMAGE WAS NOT LIKELY TO HAVE BEEN CAUSED BY ANY FACTOR RELATED TO THE MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    DORNIER WAS CONTACTED WITH A REPORT OF A DEFECTIVE LASER FIBER. THE CUSTOMER STATED, "ONE OF THE FIBERS' CONNECTOR WAS BROKEN. ALL FIBERS WERE MOVING BACK AND FORTH BEFORE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2408835 DORNIER MEDTECH AMERICA, INC. HOLMIUM LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. K2013162 MULTIPLE LOTS (2)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown