BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3113141 · Received May 9, 2013

    Report

    Report Number
    2937094-2013-00560
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 12, 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: THE FIBER GLASS CAP WAS FOUND TO HAVE A CIRCUMFERENTIAL FRACTURE AT THE FIBER BEVELED EDGE. THE GLASS CAP PROXIMAL TO THE FRACTURE WAS FOUND TO ROTATE INDEPENDENTLY OF THE METAL CAP. DETRITUS ON THE METAL CAP WAS ALSO OBSERVED. 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. THE CIRCUMFERENTIAL FRACTURE MAY ALSO RESULT IN A FORWARD-FIRING CONDITION OF THE SIDE-FIRING SURGICAL FIBER. THE MOST PROBABLE ROOT CAUSE OF THE DEVICE ISSUE WAS DETERMINED TO BE LOCALIZED 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 WAS OBSERVED AND THE LASER SYSTEM WENT INTO STANDBY MODE AT 131,772 JOULES OF USE. THE CASE WAS COMPLETED USING A SECOND FIBER. THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204979 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 246A

    Patients

    Seq Age Sex Outcome Treatment
    1