BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER MEDTECH AMERICA, INC.

    MDR report key: 19312174 · Received May 14, 2024

    Report

    Report Number
    1037955-2024-00014
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Report Date
    May 14, 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

    NO DEVICE HAS BEEN RETURNED FOR EVALUATION AT THIS TIME, HOWEVER, THE CUSTOMER REPORTED THE COMPLAINT SAMPLE IS OBTAINABLE AND WILL BE RETURNED. IF DMTA RECEIVES THE COMPLAINT SAMPLE A SUPPLEMENTAL REPORT WILL BE FILED CONTAINING DETAILS OF THE EVALUATION. 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. A ROOT CAUSE IS NOT POSSIBLE TO CONFIRM WITHOUT OPPORTUNITY TO REVIEW THE DEVICES IDENTIFIED. IT IS ACKNOWLEDGED NO MANUFACTURING DEFECTS OR INCONSISTENCIES HAVE BEEN REVEALED.

    Description of Event or Problem · 0

    2 HOLMIUM FIBERS REPORTEDLY BURNED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925545 DORNIER MEDTECH AMERICA, INC. HOLMIUM LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. K2013162

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown