BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORNIER MEDTECH AMERICA, INC.

    MDR report key: 17607281 · Received August 23, 2023

    Report

    Report Number
    1037955-2023-00029
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Report Date
    July 24, 2023
    Manufacturer
    DORNIER MEDTECH AMERICA, INC.
    Product Code
    GEX
    UDI-DI
    04049958003158
    PMA / PMN Number
    K123385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO UNITS WERE RETURNED TO DMTA WITHIN THE TIMEFRAME OF THIS INVESTIGATION. IT IS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE OF THE COMPLAINT AS REPORTED WITHOUT ACCESS TO THE DEVICES IN QUESTION. HOWEVER, ONE OF THE UNITS IDENTIFIED IS ACKONWLEDGED TO HAVE BEEN REPORTEDLY UTILIZED 12 TIMES, WHICH IS OUTSIDE OF THE APPROVED USE LIMIT OF 10 USES. THE CUSTOMER WAS NOTIFIED OF THE USE LIMIT AND INSTRUCTED TO REVIEW THE VALID INSTRUCTIONS FOR USE FOR CONFIRMATION REGARDING THE USE LIMIT. IT IS ACKNOWLEDGED THERE COULD BE MANY ROOT CAUSES FOR THE COMPLAINT INFORMATION RECEIVED, FIBER BURN. IT IS ALSO ACKNOWLEDGED THAT ALL LASER FIBERS MANUFACTURED BY DMTA ARE 100% INSPECTED FOR POWER PERFORMANCE DEFECTS, OBJECTIVELY PROVIDING CONFIRMATION THE FIBERS ARE OPERATING AS INTENDED PRIOR TO DISTRIBUTION. NO TREND FOR COMPLAINTS RELATED TO THIS MATTER IS CURRENTLY OBSERVED. DORNIER WILL CONTINUE TO MONITOR COMPLAINTS RELATED TO THIS REPORT.

    Description of Event or Problem · 0

    TWO HOLMIUM LASER FIBERS REPORTEDLY BURNED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137787 DORNIER MEDTECH AMERICA, INC. HOLMIUM LASER FIBER GEX DORNIER MEDTECH AMERICA, INC. K2013151 F4522R 04049958003158

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown