BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER HOLMIUM LASER FIBER

    MDR report key: 9158348 · Received October 4, 2019

    Report

    Report Number
    1037955-2019-00041
    Event Type
    Malfunction
    Date Received
    October 4, 2019
    Date of Event
    September 5, 2019
    Report Date
    September 9, 2019
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    UDI-DI
    00810116020348
    PMA / PMN Number
    K123385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIBER WAS EVALUATED, AND IT WAS NOTED A BREAK OCCURRED AT APPROXIMATELY 11 INCHES FROM THE DISTAL TIP. THE RETURNED SAMPLE WAS RE-CLEAVED AND TESTED TO RELEASE SPECIFICATIONS. THE OBSERVED VALUES DURING THE EVALUATION WERE NOTED TO BE WITHIN SPECIFICATION AND NO FAILURES WERE NOTED. IT IS ACKNOWLEDGED THE RFID SCAN INDICATES THE FIBER WAS POWER TESTED, AND RELEASED WITHIN SPECIFICATION ON 1 JULY 2019. AS EVIDENCED BY THE LAST USE INDICATION FROM THE RFID SCAN INDICATING A POWER SETTING OF 15 WATTS AND A TOTAL ENERGY ACCUMULATED OF 3120 JOULES, IT CAN BE CALCULATED THE FACILITY UTILIZED THIS FIBER FOR APPROXIMATELY 3.5 MINUTES. THESE CONFIRMATIONS DEMONSTRATE IT IS VERY UNLIKELY THERE WERE ANY MANUFACTURING FAULTS WITH THE FIBER. THE CAUSE OF THE FIBER BREAK WAS UNABLE TO BE CONFIRMED, BUT IT IS ACKNOWLEDGED NO MANUFACTURING DEFECTS WERE IDENTIFIED IN THIS INVESTIGATION, WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT AS REPORTED. THE ROOT CAUSE OF THE BREAKAGE IS RECOGNIZED TO RELATE TO THE CLINICAL APPLICATION OF THE DEVICE. AS STATED IN THE DORNIER SINGLEFLEX LASER FIBER SINGLE USE HOLMIUM FIBER INSTRUCTIONS FOR USE, "DORNIER SINGLEFLEX LASER FIBERS ARE FRAGILE AND MUST BE HANDLED WITH UTMOST CARE. AVOID BENDING OR COILING FIBER BEYOND THE MANUFACTURER RECOMMENDED MINIMUM BEND RADIUS (REFERENCE FIBER SPECIFICATIONS); DOING SO MAY RESULT IN LIGHT LEAKAGE OR FIBER BREAKAGE THAT COULD CAUSE PERSONAL INJURY IF LASER IS FIRED." QSF-670 REV C.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED A HOLMIUM FIBER BROKE WITHIN THE CHANNEL OF THE URETEROSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952629 DORNIER HOLMIUM LASER FIBER HOLMIUM LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. DORNIER SINGLEFLEX 200 F2619S 00810116020348

    Patients

    Seq Age Sex Outcome Treatment
    1