BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER HOLMIUM LASER FIBER

    MDR report key: 9992800 · Received April 23, 2020

    Report

    Report Number
    1037955-2020-00010
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Report Date
    March 27, 2020
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    UDI-DI
    04049958003097
    PMA / PMN Number
    K123385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THE DEVICE AVAILABLE FOR RETURN CONFIRMED THE UNIT WAS SEPARATED AS ORIGINALLY REPORTED. THE PROBABLE CAUSE OF THE SEPARATION OF THE UNIT WAS A BURNING WHICH OCCURRED LIKELY DUE TO ERRANT LASER ENERGY. THIS WAS EVIDENCED BY THE CHARACTERISTICS OF THE OBSERVED BURNING ON THE HOLMIUM FIBER WHICH WAS SEEN PREDOMINATELY ON ONE SIDE OF THE FIBERS PROXIMAL END. NO OTHER DEFECTS OR INCONSISTENCIES WERE NOTED UPON REVIEW OF THE RETURNED HOLMIUM FIBER. THE SMA HOUSING WAS NOT PROVIDED WITH THE RETURNED SAMPLE AND THEREFORE A VERIFICATION OF THE INFORMATION CONTAINED ON THE RFID CHIP WAS NOT POSSIBLE. IT IS ACKNOWLEDGED THAT ALL HOLMIUM FIBER UNITS ARE SUBJECT TO 100% POWER TESTING PRIOR TO RELEASE FOR DISTRIBUTION BY DMTA QUALITY TO ENSURE CAPABILITY OF TRANSMISSION. THE STATE OF THE CUSTOMER LASER WAS NOT CONFIRMED IN THIS INVESTIGATION. REGARDING THE SECOND INSTANCE REPORTED INVOLVING A BREAKAGE OF THE FIBER WHICH RESULTED IN A SMALL BURN TO DRAPING AND THE PATIENTS THIGH, AS STATED IN THE DORNIER HOLMIUM FIBER IFU, QSF-388, "DORNIER SINGLEFLEX¿ ARE FRAGILE AND MUST BE HANDLED WITH UTMOST CARE. AVOID BENDING OR COILING FIBER BEYOND THE MANUFACTURER RECOMMENDED MINIMUM BEND RADIUS (REFERENCE FIBER SPECIFICATIONS SECTION); DOING SO MAY RESULT IN LIGHT LEAKAGE OR FIBER BREAKAGE THAT COULD CAUSE PERSONAL INJURY IF LASER IS FIRED (REFER TO LASER OPERATOR'S MANUAL)." THE CAUSE OF THIS REPORTED EXPERIENCE IS ACKNOWLEDGED TO NOT RELATE TO A MANUFACTURING DEFECT AND IS UNDERSTOOD TO RELATE TO AN UNINTENDED EXTERNAL FORCE PLACED ON THE UNIT. NO FURTHER UPDATES REGARDING THE PATIENT CONDITION WERE PROVIDED FROM THE COMPLAINANT. NO SERIOUS INJURY WAS REPORTED.

    Description of Event or Problem · 1

    COMPLAINANT REPORTED TWO LASER FIBERS WERE OBSERVED TO BE BROKEN. ONE REPORTEDLY "SEPARATED" AND THE OTHER WAS OBSERVED TO "SNAP". BOTH INSTANCES OCCURRED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455000 DORNIER HOLMIUM LASER FIBER HOLMIUM LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. K2013062 F3619S 04049958003097

    Patients

    Seq Age Sex Outcome Treatment
    1