BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2934985 · Received January 25, 2013

    Report

    Report Number
    2937094-2013-00148
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) REFERS TO FORWARD-FIRING OF THE SIDE-FIRING SURGICAL FIBER; A CODE REQUEST HAS BEEN SUBMITTED. THE COMPONENT CODES REFER TO THE RESULTS CODE. FIBER ANALYSIS SHOWS: THE GLASS CUP IS DETACHED. THE FIBER IS BROKEN DISTAL TO FUSION ZONE. THE GLASS CAP HAS NOT BEEN RETURNED WITH THE PRODUCT. THERE IS MINIMAL DETRITUS NOTED ON METAL CAP SURFACES. THE METAL CAP SHOWS MINIMAL SIGNS OF OVERHEATING. THE GLUE HEATED TO THE POINT OF BURNING CAUSING THE GLASS CAP/FIBER TO BECOME LOOSE WITHIN THE METAL CAP AND (BECOME) DETACHED. THE IDENTIFIED ISSUES NOTED ABOVE MAY ACTIVATE THE FIBERLIFE FUNCTION WHICH WOULD MODULATE THE POWER SHOWING A PULSING BEAM OR SYSTEM WOULD BE PLACED INTO STANDBY MODE. THE POTENTIAL FOR FORWARD FIRING MAY EXIST. THE MOST PROBABLE ROOT CAUSE THAT CONTRIBUTED TO THIS FAILURE WAS SUSPECTED TO BE RELATED TO LOCALIZED HEAT ACCUMULATION/USER HANDLING DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. REF: MFR 2937094-2013-00147.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE, THE FIRST FIBER CAP DETACHED AT 80,000J. THE SECOND FIBER CAP DETACHED AT 80,507J. REPORTEDLY, BOTH CAPS DETACHED OUTSIDE THE PATIENT. A THIRD FIBER WAS USED TO COMPLETE THE CASE AT 146,890J. THIS REPORT IS FOR THE SECOND FIBER. PATIENT OUTCOME: "NO PATIENT INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36219 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 238A

    Patients

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