BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER MEDTECH AMERICA, INC.

    MDR report key: 19740864 · Received July 15, 2024

    Report

    Report Number
    1037955-2024-00024
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Report Date
    July 12, 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 WHICH WAS CONSISTENT WITH COMMENTS RECEIVED FROM THE COMPLAINANT. THE LASER FIBER DID NOT EXHIBIT ANY MANUFACTURING DEFECTS, AND IT WAS NOTED UPON REVIEW OF THE RFID INFORMATION THAT THE LASER FIBER WAS UTILIZED FOR A TOTAL OF 17290J, WHICH PROVIDES OBJECTIVE EVIDENCE THE LASER FIBER WAS OPERATING AS INTENDED. ADDITIONALLY, 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. A ROOT CAUSE FOR THE FIBER BREAKAGE WAS LIKELY DUE TO HANDLING OR MECHANICAL FORCE PLACED ON THE LASER FIBER. IT IS RECOGNIZED THAT THE CUSTOMER ALSO STATED THE LASER FIBER WAS "DROPPED". IT IS ALSO ACKNOWLEDGED THAT DURING REVIEW OF THE LASER FIBER RETURNED, BURN DAMAGE WAS NOTED AT THE SMA CONNECTOR. THE BREAKAGE OF THE FIBER AND BURN DAMAGE NOTED ARE RECOGNIZED TO BE UNRELATED TO THE DEVICES OPERATIONAL CAPACITY, AS NO MANUFACTURING DEFECTS WERE REVEALED DURING THE EVALUATION OF THE DEVICE.

    Description of Event or Problem · 0

    A HOLMIUM FIBER WAS REPORTEDLY BROKE DURING USAGE. THE CUSTOMER STATED, "IT BROKE WHEN IT WAS BEING PLACED" PRIOR TO THE OPERATION BEGINNING. ADDITIONALLY, THE CUSTOMER STATED THAT THE, "CONNECTOR CAME APART WHEN THE FIBER WAS DROPPED WHEN THE FIBER WAS REPLACED TO ANOTHER ONE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459170 DORNIER MEDTECH AMERICA, INC. HOLMIUM LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. K2013152 B4522R

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown