BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3823304 · Received February 19, 2014

    Report

    Report Number
    2937094-2014-03052
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    November 4, 2013
    Report Date
    December 16, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPONENT CODES FIBER AND CAP REFER TO THE RESULTS CODE THERMAL PROBLEM. FIBER ANALYSIS: THE FIBER EXHIBITED A CIRCUMFERENTIAL FRACTURE DISTAL TO FIBER/CAP FUSION ZONE AT THE BEVEL EDGE. THE GLASS CAP EXHIBITED SEVERE DEVITRIFICATION AT THE OUTPUT WINDOW. THE METAL CAP EXHIBITED MILD BURNT ON DETRITUS. THE FIBER PROXIMAL TO FRACTURE ROTATED INDEPENDENTLY OF METAL CAP. 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, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. THE PROBABLE ROOT CAUSE: LOCALIZED HEAT ACCUMULATION DUE TO USER HANDLING AND OR ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, RESULTING IN ACCELERATED CAP WEAR, LIMITING THE PERFORMANCE OF THE FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROSTATE PROCEDURE @ 18 MINUTES, 48 SECONDS AND 116,627 JOULES OF USE, THE FIBER CARD WAS NOT PERMITTING FUNCTION. THE PROCEDURE WAS COMPLETED WITH A SECOND FIBER. PATIENT OUTCOME: "NO PATIENT INJURY REPORTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104662 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 330A

    Patients

    Seq Age Sex Outcome Treatment
    1