BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER MEDTECH AMERICA, INC.

    MDR report key: 19166430 · Received April 23, 2024

    Report

    Report Number
    1037955-2024-00011
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    March 7, 2024
    Report Date
    March 27, 2024
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    UDI-DI
    04049958003158
    PMA / PMN Number
    K123385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE RETURNED FOR EVALUATION WAS ANALYZED AND IT WAS DETERMINED NO MANUFACTURING DEFECTS WERE PRESENT WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT AS REPORTED. 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. IT IS POSSIBLE THE ROOT CAUSE RELATED TO AN OVERHEATING OF THE DEVICE EITHER DURING USAGE OR DUE TO STERILIZATION FAILURE OR INCORRECT STERILIZATION PRACTICES, HOWEVER, THIS CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    HOLMIUM FIBER REPORTEDLY DEFECTIVE AND OBSERVED WITH THE "TOP OF THE SMA PIN CHARRED", POSSIBLY INDICATING A FIBER BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273065 DORNIER MEDTECH AMERICA, INC. HOLMIUM LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. K2013151 F4522R 04049958003158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown