BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3131207 · Received May 23, 2013

    Report

    Report Number
    2937094-2013-00618
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    October 16, 2012
    Report Date
    April 2, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES FIBER AND CAP REFER TO THE RESULTS CODE THERMAL PROBLEM. FIBER ANALYSIS: THE FIBER WAS FOUND TO HAVE A CIRCUMFERENTIAL FRACTURE OF THE GLASS CAP, DISTAL TO THE FIBER/CAP FUSION ZONE; SEVERE DEVITRIFICATION WAS OBSERVED AT THE OUTPUT WINDOW. THE FIBER PROXIMAL TO THE FRACTURE WAS FOUND TO ROTATE INDEPENDENTLY OF THE METAL CAP; DETRITUS AND CHAR WAS ALSO OBSERVED ON THE METAL CAP. 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 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 DURING A "PROSTATE RESECTION," THE FIBER TIP WAS DAMAGED AT 100,187 JOULES OF USE. THE PROCEDURE WAS COMPLETED USING A SECOND FIBER. THE PATIENT CONDITION BEFORE AND AFTER THE EVENT WAS "SATISFACTORY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230021 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 228A

    Patients

    Seq Age Sex Outcome Treatment
    1