BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER MEDTECH AMERICA, INC.

    MDR report key: 19822757 · Received July 24, 2024

    Report

    Report Number
    1037955-2024-00028
    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 DEVICE RETURNED FOR EVALUATION WAS REVIEWED AND IT WAS CONFIRMED THAT THE FIBER WAS BROKEN IN TWO PLACES AS 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 FOUR USES CONSISTENT WITH INFORMATION RECEIVED FROM THE CUSTOMER, WHICH PROVIDES OBJECTIVE EVIDENCE THE LASER FIBER WAS AT LEAST OPERATING AS INTENDED PRIOR TO THE BREAKAGES OBSERVED OCCURRING. 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 LIKELY THE ROOT CAUSE OF THE BREAKAGE RELATED TO THE HANDLING OF THE LASER FIBER, SUCH AS A MECHANICAL FORCE PLACED ON THE UNIT WHICH RESULTED IN THE BREAKAGE. 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 REPORTEDLY DEFECTIVE. THE CUSTOMER STATED THEY, "TRIED TO USE THE FIBER THAT HAD BEEN USED 4 TIMES BUT NO LASER EMISSION CAME OUT OF THAT FIBER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2408836 DORNIER MEDTECH AMERICA, INC. HOLMIUM LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. K2013152 B0621R

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown