BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2941217 · Received January 18, 2013

    Report

    Report Number
    2937094-2013-00108
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    October 9, 2012
    Report Date
    October 24, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 CAP EXHIBITS A RADIAL FRACTURE AT THE OUTPUT WINDOW OF THE CAP; THE FIBER IS FRACTURED DISTAL TO THE FIBER/CAP FUSION ZONE. THE FIBER PROXIMAL TO FRACTURE ROTATES INDEPENDENTLY OF METAL CAP. THE METAL CAP SHOWS SIGNS OF BURNT ON DETRITUS AND THE GLASS CAP SHOWS SIGNS OF DEVITRIFICATION. THE FIBER/CAP CONDITIONS WOULD RESULT IN FORWARD FIRING. THE MOST PROBABLE ROOT CAUSE THAT CONTRIBUTED TO THIS FAILURE WAS SUSPECTED TO BE RELATED TO LOCALIZED HEAT ACCUMULATION/USER HANDLING DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS DECREASED VAPORIZATION AT 83,786 JOULES. THE CASE WAS COMPLETED WITH A SECOND FIBER. NO INJURY TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28400 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 202B

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT XPS LASER SYSTEM AND ACCESSORIES