BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 8732861 · Received June 25, 2019

    Report

    Report Number
    2937094-2019-60722
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Date of Event
    May 28, 2019
    Report Date
    July 26, 2019
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC
    Product Code
    GEX
    UDI-DI
    00878953005515
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICES MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ANALYSIS OF THE DEVICE REVEALED THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT OUTPUT WINDOW. THE METAL CAP EXHIBITS SEVERE CHARRED DETRITUS ADHESION ON SURFACE. CAP WEAR IS A KNOWN INHERENT RISK OF DEVICE. CAP WEAR WAS ACCELERATED DUE TO ANATOMICAL/PROCEDURAL FACTORS (TISSUE CONTACT AND TECHNIQUE) ENCOUNTERED DURING THE PROCEDURE WHICH WOULD LIMIT THE PERFORMANCE OF THE FIBER. 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. THIS WOULD CAUSE REDUCED VAPORIZATION EFFICIENCY. IN ADDITION, ANALYSIS IDENTIFIED THE GLASS CAP HAS A CIRCUMFERENTIAL FRACTURE ON THE DISTAL SIDE OF FIBER/CAP FUSION ZONE AT THE BEVEL EDGE. THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF OUTER FLOW TUBING. THE OUTER FLOW TUBING OPEN END EXHIBITS MINOR SCRATCH MARKS. THE POTENTIAL FOR FORWARD FIRING MAY EXIST. DUE TO THE OBSERVED GLASS CAP DISTAL FRACTURE, AN EVALUATION CONCLUSION CODE OF DESIGN INADEQUATE FOR PURPOSE OF THE DEVICE WAS ASSIGNED TO THIS INVESTIGATION. IT IS PROBABLE THAT A TEMPERATURE HIGHER OR CLOSE TO EPOXY DEGRADATION TEMPERATURE NEAR THE LASER BEAM OUTPUT WINDOW MAY BE A MAJOR IMPACTING FACTOR LEADING TO EPOXY FAILURE AND SUBSEQUENT FIBER BREAKAGE. TISSUE ADHESION FROM CONSTANT AND HEAVY TISSUE CONTACT COULD BE THE CAUSE RESULTING IN THE OBSERVED CIRCUMFERENTIAL FRACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LASER BEAM WAS COMING STRAIGHT OUT OF THE TIP OF FIBER AFTER 180497 JOULES OF USE. THE FIBER TIP WAS NOT CLEANED DURING THE PROCEDURE. THE CASE WAS COMPLETE WITH ANOTHER FIBER AND THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LASER BEAM WAS COMING STRAIGHT OUT OF THE TIP OF FIBER AFTER 180497 JOULES OF USE. THE FIBER TIP WAS NOT CLEANED DURING THE PROCEDURE. THE CASE WAS COMPLETE WITH ANOTHER FIBER AND THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525907 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC 0010-2400 0023140183 00878953005515

    Patients

    Seq Age Sex Outcome Treatment
    1