BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3042288 · Received April 1, 2013

    Report

    Report Number
    2937094-2013-00414
    Event Type
    Malfunction
    Date Received
    April 1, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 2, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER ANALYSIS: A CIRCUMFERENTIAL FRACTURE OF THE GLASS CAP WAS FOUND, DISTAL TO THE FIBER/CAP FUSION ZONE; THE FIBER PROXIMAL TO THE FRACTURE WAS FOUND TO ROTATE INDEPENDENTLY OF THE METAL CAP. THE FIBER NEAR THE GLUE ADHESION REMAINS INTACT WITH THE METAL CAP AND DOES NOT ROTATE. THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION NEAR THE OUTPUT WINDOW. THE METAL CAP HAS SEVERE BURNT/CHAR, DETRITUS, AND DEVITRIFICATION. THE IDENTIFIED ISSUES MAY ACTIVATE THE FIBERLIFE FUNCTION WHICH WOULD MODULATE THE POWER SHOWING A PULSING BEAM OR THE SYSTEM WOULD BE PLACED INTO STANDBY MODE. THIS ISSUE MAY ALSO CAUSE FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER. THE MOST PROBABLE ROOT CAUSE THAT CONTRIBUTED TO THIS 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 WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, DIMINISHED TISSUE VAPORIZATION EFFICIENCY WAS OBSERVED AT 557,065 JOULES OF USE. THE CASE WAS COMPLETED USING A SECOND FIBER. PT OUTCOME: "NO DAMAGES TO THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131964 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 240A

    Patients

    Seq Age Sex Outcome Treatment
    1