BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2926519 · Received January 17, 2013

    Report

    Report Number
    2937094-2013-00082
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Date of Event
    October 17, 2012
    Report Date
    October 17, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES: FIBER AND CAP REFER TO THE RESULTS CODE THERMAL PROBLEM. FIBER ANALYSIS: THE FIBER EXHIBITED A CIRCUMFERENTIAL FRACTURE OF GLASS CAP DISTAL TO THE FIBER/CAP FUSION ZONE. THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF METAL CAP. THE METAL CAP HAS BURNT ON DETRITUS AND DEVITRIFICATION OF CAP AT OUTPUT WINDOW. THE ISSUES MAY ACTIVATE THE FIBERLIFE FUNCTION WHICH WILL MODULATE THE POWER SHOWING A PULSING BEAM OR SYSTEM WOULD BE PLACED INTO STANDBY MODE. THE POTENTIAL FOR FORWARD FIRING MAY EXIST. THE PROBABLE ROOT CAUSE THAT CONTRIBUTED TO THE FAILURE WAS SUSPECTED TO BE RELATED LOCALIZED HEAT ACCUMULATION/ USER HANDLING DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS SIGNIFICANTLY DIMINISHED VAPORIZATION AT 20,982 JOULES DURING THE PROCEDURE. THE CASE WAS COMPLETED WITH A SECOND FIBER. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26168 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 229A

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORIES| GRENLIGHT XPS LASER SYSTEM