BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3151445 · Received May 30, 2013

    Report

    Report Number
    2937094-2013-00631
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    December 3, 2012
    Report Date
    January 21, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES 814 FIBER AND 424 CAP REFER TO THE RESULTS CODE 642 THERMAL PROBLEM. FIBER ANALYSIS: THE GLASS CAP IS FRACTURED PROXIMAL TO THE FUSION ZONE. THE FRACTURED GLASS CAP PORTION DISTAL TO THE FUSION ZONE IS MISSING. METAL CAP EXHIBITS CHAR, WHITE CRYSTALLINE RESIDUE, AND DETRITUS ON THE CAP SURFACE. PROXIMAL PORTION OF GLASS CAP EXHIBITS DEVITRIFICATION. 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. BASED ON THE ANALYSIS ABOVE, THIS WOULD RESULT IN FORWARD FIRING THE MOST PROBABLE ROOT CAUSE OF THE DEVICE ISSUE WAS DETERMINED TO BE LOCALIZED HEAT ACCUMULATION/USER HANDLING CAN OCCUR WHEN TISSUE ADHERES TO THE FIBER CAP SURFACES. REFERENCE MFR # 2937094-2013-00632.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE SURGICAL FIBER DURING A PROSTATE PROCEDURE, THE FIBER BEGAN TO SHOOT STRAIGHT AT 45,000 JOULES. THE FIBER WAS REPLACED AND THE CASE WAS CONTINUED WITH A SECOND FIBER. THE SECOND FIBER ALSO BEGAN TO SHOOT STRAIGHT AT 100,000 JOULES. THE CASE WAS COMPLETED WITH A THIRD FIBER. THIS REPORT IS FOR THE FIRST FIBER. NO INFORMATION REGARDING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240173 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 238A

    Patients

    Seq Age Sex Outcome Treatment
    1