BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3042856 · Received April 4, 2013

    Report

    Report Number
    2937094-2013-00422
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    December 17, 2012
    Report Date
    January 23, 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 AND CAP REFER TO THERMAL PROBLEM. FIBER ANALYSIS: A CIRCUMFERENTIAL FRACTURE OF THE GLASS CAP WAS FOUND AT THE OUTPUT WINDOW; THE GLASS CAP/FIBER DISTAL TO THE FRACTURE WAS FOUND TO ROTATE INDEPENDENTLY OF THE METAL CAP. BURNT ON DETRITUS AND CHARRING OF THE CAP OUTPUT WINDOW 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. THIS ISSUE MAY ALSO CAUSE FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER. THE MOST PROBABLE ROOT CAUSE OF THE DEVICE FAILURE WAS DETERMINED TO BE HEAT ACCUMULATION DUE TO TISSUE CONTACT AND/OR ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE THE BEAM FROM THE SURGICAL FIBER WAS OBSERVED TO BLINK AT 299,312 JOULES OF USE. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139000 GREENLIGHT MOXY FIBER OPTIC POWERD SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 239A

    Patients

    Seq Age Sex Outcome Treatment
    1