BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER MEDTECH AMERICA, INC.

    MDR report key: 19783870 · Received July 19, 2024

    Report

    Report Number
    1037955-2024-00026
    Event Type
    Malfunction
    Date Received
    July 19, 2024
    Report Date
    July 19, 2024
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    UDI-DI
    04049958003165
    PMA / PMN Number
    K121938
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE RETURNED FOR EVALUATION WAS REVIEWED AND IT WAS CONFIRMED THAT THE FIBER WAS BROKEN AT THE PROXIMAL SMA CONNECTOR, LIKELY DUE TO BURN DAMAGE WHICH WAS ALSO OBSERVED. THE BURN DAMAGE REVEALED WAS LIKELY THE CAUSE OF THE "INTERNAL LOOSE PARTS" DESCRIBED BY THE COMPLAINANT. UPON REVIEW, THE LASER FIBER DID NOT EXHIBIT ANY MANUFACTURING DEFECTS OR INCONSISTENCIES. IT WAS NOTED UPON REVIEW OF THE RFID INFORMATION THAT THE LASER FIBER WAS UTILIZED FOR JUST OVER 2000J, WHICH PROVIDES OBJECTIVE EVIDENCE THE LASER FIBER WAS AT LEAST OPERATING AS INTENDED PRIOR TO FAILURE. 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

    A HOLMIUM FIBER WAS REPORTED TO HAVE A DEFECT WITH, "LOOSE INTERNAL PARTS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552320 DORNIER MEDTECH AMERICA, INC. HOLMIUM LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. K2013162 F2723R 04049958003165

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown