BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2934961 · Received January 25, 2013

    Report

    Report Number
    2937094-2013-00133
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    October 2, 2012
    Report Date
    November 30, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: THE FIBER WAS FOUND TO HAVE A CIRCUMFERENTIAL FRACTURE OF THE GLASS CAP, PROXIMAL TO THE FIBER/CAP FUSION ZONE. THE FIBER PROXIMAL TO THE FRACTURE CAN ROTATE INDEPENDENTLY OF THE METAL CAP. THE METAL CAP SHOWED BURNT ON DETRITUS AND DEVITRIFICATION OF THE CAP AT THE OUTPUT WINDOW. THE IDENTIFIED ISSUES NOTED MAY ACTIVATE THE FIBERLIFE FUNCTION WHICH WOULD MODULATE THE POWER SHOWING A PULSING BEAM AND SYSTEM WOULD BE PLACED INTO STANDBY MODE. THE POTENTIAL FOR FORWARD FIRING MAY EXIST. THE MOST PROBABLE ROOT CAUSE THAT CONTRIBUTED TO THIS DEVICE FAILURE WAS SUSPECTED TO BE RELATED TO HEAT ACCUMULATION / USER HANDLING DUE TO ANATOMICAL / PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE DR EXPERIENCED DIFFICULTY ROTATING THE FIBER BY THE KNOB AT 19,124 JOULES. THE CASE WAS COMPLETED BY USING A SECOND FIBER. IT WAS REPORTED NO HARM TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36714 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 231A

    Patients

    Seq Age Sex Outcome Treatment
    1