BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2854523 · Received November 29, 2012

    Report

    Report Number
    2937094-2012-01245
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 12, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIBER ANALYSIS: THE FIBER WAS FOUND TO HAVE A CIRCUMFERENTIAL FRACTURE DISTAL TO THE FIBER/CAP FUSION ZONE. THE METAL CAP WAS ALSO FOUND TO HAVE BURNT ON DETRITUS AND DEVITRIFICATION OF THE CAP OUTPUT WINDOW. THE FIBER CONDITION WOULD LIKELY RESULT IN ACTIVATION OF THE SYSTEM'S FIBERLIFE FUNCTION WHICH WILL MODULATE (PULSE) THE OUTPUT BEAM, RESULTING IN REDUCED TISSUE VAPORIZATION EFFICIENCY AND OR SENT THE SYSTEM TO STAND BY MODE. BASED ON THE ANALYSIS OF FINDINGS, THE CIRCUMFERENTIAL FRACTURE CONDITION MAY ALSO RESULT IN A FORWARD FIRING CONDITION. THE 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, RESULTING IN FIBER BREAKAGE AND CAP DAMAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED EXCESSIVE FIBERLIFE AT 160,546 JOULES. THE CASE WAS COMPLETED WITH A SECOND FIBER. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10/2400 225A

    Patients

    Seq Age Sex Outcome Treatment
    1 GREENLIGHT XPS LASER SYSTEM| ACCESSORIES