BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 7982235 · Received October 18, 2018

    Report

    Report Number
    2937094-2018-60016
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    September 18, 2018
    Report Date
    January 23, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE RETURNED TO MANUFACTURER: CORRECTION H3 DEVICE RETURNED FOR EVALUATION: UPDATED DEVICE EVALUATION CODES: ADDED THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICES MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE GLASS CAP SHOWS A CIRCUMFERENTIAL FRACTURE ON THE DISTAL SIDE OF FIBER/CAP FUSION ZONE OF THE BEVEL EDGE. THE FIBER PROXIMAL TO FRACTURE CAN ROTATE INDEPENDENTLY OF OUTER FLOW TUBING. THE GLASS CAP EXHIBITS SEVERE DEVITRIFICATION AT OUTPUT WINDOW. THE METAL CAP EXHIBITS SEVERE DETRITUS ADHESION ON SURFACE, AND INDICATION OF SLIGHT MELTING ON OUTPUT WINDOW. THE OUTER FLOW TUBING OPEN END EXHIBITS MINOR SCRATCH MARKS. BASED ON DEVICE ANALYSIS, THE POTENTIAL FOR FORWARD FIRING MAY EXIST. 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. AN EVALUATION CONCLUSION CODE OF KNOWN INHERENT RISK OF THE DEVICE WAS ASSIGNED TO THIS INVESTIGATION.THIS SUPPLEMENTAL CORRECTION REPORT IS BEING FILED TO CORRECT THE REPORT NUMBER IN A PREVIOUSLY SUBMITTED SUPPLEMENTAL REPORT (FOLLOW-UP NUMBER 001) WHICH WAS ACCEPTED BY FDA ON 12/21/2018 10:04 AM CT.THE REPORT NUMBER IS BEING CORRECTED FROM: 2937094-2018-60243TO: 2937094-2018-60016

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BENIGN PROSTATIC HYPERPLASIA SURGICAL PROCEDURE AT 283,079 JOULES THE FIBERLIFE WAS ACTIVATED, DIMINISHED VAPORIZATION WAS EXPERIENCED AND THE MACHINE WENT INTO STANDBY MODE WHEN THE FIBER WAS SWEPT UPWARDS. THE FIBER WAS EXCHANGED AND AFTER 125,807 JOULES THE SECOND FIBER BEGAN FIRING OUT OF THE TIP. THE FIBER WAS EXCHANGED AND THE THIRD FIBER WAS USED TO COMPLETE THE PROCEDURE AT 225,104 JOULES. THE TIPS OF THE FIBERS WERE CLEANED DURING THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS REPORT IS FOR THE SECOND FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BENIGN PROSTATIC HYPERPLASIA SURGICAL PROCEDURE AT 283,079 JOULES THE FIBERLIFE WAS ACTIVATED, DIMINISHED VAPORIZATION WAS EXPERIENCED AND THE MACHINE WENT INTO STANDBY MODE WHEN THE FIBER WAS SWEPT UPWARDS. THE FIBER WAS EXCHANGED AND AFTER 125,807 JOULES THE SECOND FIBER BEGAN FIRING OUT OF THE TIP. THE FIBER WAS EXCHANGED AND THE THIRD FIBER WAS USED TO COMPLETE THE PROCEDURE AT 225,104 JOULES. THE TIPS OF THE FIBERS WERE CLEANED DURING THE PROCEDURE. NO PATIENT INJURY REPORTED. THIS REPORT IS FOR THE SECOND FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819452 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. 0010-2400 0022045291 00878953005515

    Patients

    Seq Age Sex Outcome Treatment
    1