BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER HOLMIUM LASER FIBER

    MDR report key: 9238318 · Received October 25, 2019

    Report

    Report Number
    1037955-2019-00054
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Date of Event
    August 1, 2019
    Report Date
    October 17, 2019
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    UDI-DI
    00810116020027
    PMA / PMN Number
    K123385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THE RETURNED DEVICE BY DORNIER QUALITY ENGINEER CONFIRMED THE DEVICE WAS BROKEN BEFORE USE AS INDICATED BY THE COMPLAINANT. NO MANUFACTURING DEFECTS WERE NOTED UPON REVIEW OF THE DEVICE AND THE SCAN OF THE RFID TAG CONFIRMED THE UNIT WAS OPERATING AS INTENDED UPON POWER TESTING BY PRODUCTION PERSONNEL. IT IS ACKNOWLEDGED THE UNIT WAS BROKEN UPON RETURN TO DORNIER FOR EVALUATION. THE CAUSE OF THE HOLMIUM FIBER BREAKAGE CAN NOT BE CONFIRMED, HOWEVER, HOLMIUM FIBERS ARE COILED INTO A PROTECTIVE SHEATH FOR PROTECTION OF THE DEVICE AND AN EXTERNAL FORCE ON THE UNIT WOULD BE THE ONLY CAUSE OF A FIBER BREAKAGE AS OBSERVED. IT IS RECOGNIZED THE REPORTED FIBER IS A 600 MICRON UNIT AND DUE TO ITS SIZE IS CONSEQUENTLY MORE DURABLE AND LESS PRONE TO BREAKAGE. IT CAN BE CONFIRMED EACH HOLMIUM LASER FIBER IS 100% INSPECTED FOR BOTH VISUAL AND PERFORMANCE INCONSISTENCIES PRIOR TO RELEASE FOR DISTRIBUTION, INCLUDING VERIFICATIONS THE SPECIFICATION FOR REQUIRED BEND RADIUS CAN BE SUSTAINED UTILIZING A BEND TEST FIXTURE. THE COMPLAINT AS REPORTED WAS CONFIRMED BUT IT IS LIKELY THE ROOT CAUSE OF THE FIBER BREAKAGE RELATED TO EXTERNAL FORCES PLACED ON THE UNIT WHICH CAUSED AN UNINTENDED BREAKAGE. HOLMIUM FIBERS ARE FRAGILE AND MUST BE HANDLED WITH UTMOST CARE AS INDICATED IN THE APPLICABLE HOLMIUM FIBER INSTRUCTION FOR USE, QSF-474.

    Description of Event or Problem · 1

    COMPLAINANT REPORTED A DISPOSABLE LASER FIBER WAS FOUND BROKEN IN THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034700 DORNIER HOLMIUM LASER FIBER HOLMIUM LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. HLFDBX0600C C4018S 00810116020027

    Patients

    Seq Age Sex Outcome Treatment
    1