BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER MEDTECH AMERICA, INC.

    MDR report key: 20268353 · Received September 20, 2024

    Report

    Report Number
    1037955-2024-00038
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 20, 2024
    Report Date
    November 6, 2024
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    UDI-DI
    04049958003097
    PMA / PMN Number
    K121938
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICES WERE RETURNED WITHIN THE DURATION OF THIS INVESTIGATION. THE DEVICE IDENTIFIED BY THE COMPLAINT INFORMATION HAS NOT BEEN RECEIVED FOR EVALUATION. THE ROOT CAUSE OF THE COMPLAINT AS REPORTED WAS NOT POSSIBLE TO CONFIRM. HOWEVER, IT IS ACKNOWLEDGED THAT DORNIER LASER FIBERS ARE FRAGILE, AND MUST BE HANDLED WITH CARE AS INSTRUCTED IN THE APPLICABLE INSTRUCTIONS FOR USE FOR LASER FIBERS. SHOULD A LASER FIBER BE RETURNED ALLOWING FURTHER ANALYSIS, DETAILS CONCERNING THE EVALUATION WILL BE PROVIDED IN A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 0

    ONE LASER FIBER WAS RETURNED FOR EVALUATION BASED ON THE COMPLAINT AS REPORTED. THE LASER FIBER RETURNED WAS CONFIRMED TO BE ITEM K2013062 LOT F2723S, AND WAS CONFIRMED TO BE BROKEN AS DESCRIBED BY THE COMPLAINANT. UPON VERIFICATION OF THE RFID, IT WAS REVEALED THE LASER WAS POWER PERFORMANCE TESTED ACCEPTABLY BY DMTA PERSONNEL, CONFIRMING THE ACCEPTABLE OPERATION OF THE DEVICE. ADDITIONALLY, A SMALL AMOUNT OF USAGE WAS RECORDED ON THE LASER FIBER, INDICATING PERHAPS A MECHANICAL FORCE PLACED ON THE LASER FIBER OCCURRED EARLY ON DURING OPERATION. IT IS ACKNOWLEDGED THAT DORNIER LASER FIBERS ARE FRAGILE, AND MUST BE HANDLED WITH CARE AS INSTRUCTED IN THE APPLICABLE INSTRUCTIONS FOR USE FOR LASER FIBERS. NO MANUFACTURING DEFECTS WERE REVEALED.

    Description of Event or Problem · 0

    DMTA QUALITY WAS CONTACTED REGARDING A HOLMIUM LASER FIBER WHICH WAS REPORTED TO HAVE BROKEN, "A URS TREATMENT HAS BEEN CONDUCTED IN WHICH A LASER FIBER WAS BROKEN".

    Description of Event or Problem · 0

    DMTA QUALITY WAS CONTACTED REGARDING A HOLMIUM LASER FIBER WHICH WAS REPORTED TO HAVE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354129 DORNIER MEDTECH AMERICA, INC. HOLMIUM LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. K2013062 F2723S 04049958003097

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown