BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER HOLMIUM LASER FIBER

    MDR report key: 11609281 · Received April 2, 2021

    Report

    Report Number
    1037955-2021-00016
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Report Date
    March 12, 2021
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    UDI-DI
    04049958003158
    PMA / PMN Number
    K123385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPLAINT FIBERS WERE RECEIVED WITHIN THE TIMEFRAME OF INVESTIGATION. IT CAN BE CONFIRMED HOLMIUM LASER FIBERS ARE SUBJECT TO 100% INSPECTION FOR BOTH VISUAL AND POWER TESTING PERFORMANCE DEFECTS PRIOR TO RELEASE FOR DISTRIBUTION. NO PROCESS DEVIATIONS WERE IDENTIFIED UPON REVIEW OF THE COMPLAINT PRODUCTION LOT RECORDS. THE ROOT CAUSE OF THIS COMPLAINT WAS NOT CONFIRMED BUT WITH CONSIDERATION OF THE INFORMATION AVAILABLE IT IS LIKELY IT MAY BE RELATED TO THE STATE OF THE CUSTOMER LASER, SUCH AS ALIGNMENT, OR ALSO THE RE-STERILIZATION PROCESS CONDUCTED ON THE FIBERS IDENTIFIED.

    Description of Event or Problem · 1

    A NOTIFICATION WAS RECEIVED REGARDING A HOLMIUM FIBER UNIT WHICH WAS REPORTED TO HAVE BURNED DURING USE. NO PATIENT HARM OR IMPACT WAS REPORTED. ADDITIONAL COMPLAINT EXPERIENCES WERE REPORTED BY THE SAME CUSTOMER, LASER DEVICES NOT RECOGNIZING FIBERS, FIBERS NOT TRANSMITTING POWER PROPERLY, LOOSE CONNECTORS, FIBERS NOT WORKING. A TOTAL OF 7 UNITS WERE REPORTED FOR THREE SEPARATE PRODUCTION LOTS OF FIBERS UNDER TWO DIFFERENT PRODUCT ID'S. K2013151, LOT F0120R - 3 UNITS. K2013152 LOT B1018R - 3 UNITS. K2013151 LOT F0320R - 1 UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507389 DORNIER HOLMIUM LASER FIBER HOLMIUM LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. K2013151 F0120R 04049958003158

    Patients

    Seq Age Sex Outcome Treatment
    1