BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2936842 · Received January 15, 2013

    Report

    Report Number
    2937094-2013-00076
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    October 25, 2012
    Report Date
    October 29, 2012
    Manufacturer
    AMS INNOVATIVE CENTER-SAN JOSE
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES FOR FIBER AND CAP REFER TO THE RESULTS CODE FOR THERMAL PROBLEM. 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 CAN ROTATE INDEPENDENTLY OF THE METAL CAP. THE METAL CAP SHOWED BURNT ON DETRITUS AND DEVITRIFICATION OF THE CAP AT THE OUTPUT WINDOW. IT WAS ALSO FOUND THE OUTER FLOW TUBING WAS TWISTED AROUND THE FIBER SHAFT, THERE ARE INDICATIONS OF ABRASIONS AND LACERATIONS, PROBABLE CAUSE WOULD BE USER HANDLING. THE FIBER CONDITION WOULD LIKELY RESULT IN ACTIVATION OF THE SYSTEMS FIBERLIFE FUNCTION WHICH WILL MODULATE (PULSE) THE OUTPUT BEAM, RESULTING IN 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 SIDE-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

    IT WAS REPORTED FIBER DAMAGE AT TIP AT 354,077 JOULES OF USE DURING A PROSTATE PROCEDURE. THE CASE WAS COMPLETED USING A SECOND FIBER WITHOUT FURTHER ISSUE. PATIENT WAS REPORTED TO BE ¿OK¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21985 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMS INNOVATIVE CENTER-SAN JOSE 10-2400 232A

    Patients

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