BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 7988178 · Received October 20, 2018

    Report

    Report Number
    2937094-2018-60017
    Event Type
    Malfunction
    Date Received
    October 20, 2018
    Date of Event
    August 2, 2018
    Report Date
    January 29, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PREMARKET / 510(K) #: ADDED. DEVICE RETURNED TO MANUFACTURER: UPDATED. DEVICE RETURNED FOR EVALUATION: UPDATED. DEVICE EVALUATION CODES: UPDATED. THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICES MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE FIBER TIP EXHIBITS NO SIGNS OF USAGE. THERE ARE NO SIGNS OF FIBER TIP BREAKS\FRACTURES. THE FIBER WAS TESTED WITH HENE LASER FIXTURE, AIM BEAM IS PRESENT AT FIBER OUTPUT WINDOW. THERE ARE NO SIGNS OF BREAKAGE ALONG LENGTH OF FIBER. THE CONNECTOR CONE, SEGMENTS, AND TABS APPEAR IN GOOD CONDITION AND SECURED. THE FIBER CONNECTOR PASSED THE SIGNATURE VERIFICATION FIXTURE TEST. THERE ARE NO SIGNS OF BREAKAGE AT FIBER TIP, AND HENE TEST CONFIRMS LIGHT BEAM AT OUTPUT WINDOW. AN EVALUATION CONCLUSION CODE OF NO PROBLEM DETECTED WAS ASSIGNED TO THIS INVESTIGATION. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENTS OF A REPORTABLE EVENT FOR THE DEVICE IN QUESTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BENIGN PROSTATIC HYPERPLASIA SURGICAL PROCEDURE AT 7,861 JOULES AND 1:20 MINUTES THE FIBER WAS NOT FIRING AND BEGAN END FIRING. THE FIBER WAS EXCHANGED AND THE SECOND FIBER WAS USED TO COMPLETE THE PROCEDURE. FINE PATIENT OUTCOME REPORTED.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BENIGN PROSTATIC HYPERPLASIA SURGICAL PROCEDURE AT 7,861 JOULES AND 1:20 MINUTES THE FIBER WAS NOT FIRING AND BEGAN END FIRING. THE FIBER WAS EXCHANGED AND THE SECOND FIBER WAS USED TO COMPLETE THE PROCEDURE. FINE PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828447 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. 0010-2400 0022075868 00878953005515

    Patients

    Seq Age Sex Outcome Treatment
    1