BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3131212 · Received May 23, 2013

    Report

    Report Number
    2937094-2013-00623
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    February 1, 2013
    Report Date
    April 11, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER ANALYSIS: THE FIBER'S GLASS CAPS WAS FOUND TO BE DETACHED AND THE FIBER BROKEN PROXIMAL TO THE FUSION ZONE; THERE WAS NO INDICATION OR REPORT OF ANY PART OF THE DEVICE REMAINING INSIDE THE PT. THE METAL CAP SHOWED SIGNS OF CHAR AND DETRITUS. 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 RESULT IN A FORWARD-FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER. THE PROBABLE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION/USER HANDLING DUE TO TISSUE CONTACT AND OR 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, A "STROBOSCOPE" ISSUE WAS OBSERVED (THE SYSTEMS FIBERLIFE MODE WAS ACTIVATED) AT 167,144 JOULES OF USE. THE CASE WAS COMPLETED USING A SECOND FIBER. "NO DAMAGES TO THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228497 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 244B

    Patients

    Seq Age Sex Outcome Treatment
    1