BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2913510 · Received January 9, 2013

    Report

    Report Number
    2937094-2013-00046
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    February 29, 2012
    Report Date
    March 19, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS: THE FIBER WAS FOUND TO HAVE A RADIAL FRACTURE OF THE GLASS CAP PROXIMAL TO THE FIBER/CAP FUSION ZONE; THE FIBER PROXIMAL TO THE FRACTURE WAS FOUND TO ROTATE INDEPENDENTLY OF THE METAL CAP. THE FIBER CONDITION WOULD LIKELY RESULT IN ACTIVATION OF THE SYSTEMS FIBERLIFE FUNCTION WHICH WILL MODULATE (PULSE) THE OUTPUT BEAM, RESULTING THE REDUCED TISSUE VAPORIZATION EFFICIENCY AND OR SEND THE SYSTEM TO STANDBY MODE. THE FIBER/CAP CONDITION COULD ALSO RESULT IN FORWARD FIRING CONDITION OF THE SID-FIRING SURGICAL FIBER. 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 BREAKAGE OF THE SURGICAL FIBER AT 6,000 JOULES OF USE DURING A PROSTATE PROCEDURE. THE CASE WAS COMPLETED BY TURP. THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13158 GREENLIGHT MOXY FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 10-2400 147A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GREENLIGHT XPS LASER SYSTEM AND ACCESSORIES