BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3202256 · Received June 28, 2013

    Report

    Report Number
    2937094-2013-00712
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 25, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER ANALYSIS: THE FIBER WAS FOUND TO HAVE A CIRCUMFERENTIAL FRACTURE OF THE GLASS CAP DISTAL TO THE FIBER/CAP FUSION ZONE; THE FIBER PROXIMAL TO THE FRACTURE WAS FOUND TO ROTATE INDEPENDENTLY OF THE METAL CAP. DEVITRIFICATION AT THE CAP OUTPUT WINDOW WAS ALSO OBSERVED. THE IDENTIFIED ISSUES MAY ACTIVATE THE LASER SYSTEMS FIBERLIFE FUNCTION WHICH WOULD MODULATE THE POWER SHOWING A PULSING BEAM OR THE SYSTEM WOULD BE PLACED INTO STANDBY MODE. THE FRACTURED GLASS CAP 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, THE FIBERS TIP WAS DAMAGED AT 115,592 JOULES OF USE. THE PROCEDURE WAS COMPLETED USING A SECOND FIBER. THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295092 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 251A

    Patients

    Seq Age Sex Outcome Treatment
    1