BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 8190562 · Received December 21, 2018

    Report

    Report Number
    2937094-2018-60262
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Date of Event
    December 1, 2018
    Report Date
    January 14, 2019
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K120870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION: UPDATED . MANUFACTURER NAME: CORRECTED. PRODUCT INFORMATION: ADDED. INITIAL REPORTER ADDRESS: CORRECTED. REPORT SOURCE: CORRECTED. PREMARKET / 510(K): ADDED. THIS REPORT IS FOR THE SAME EVENT AS MANUFACTURER REPORT: 2937094-2018-60266.

    Description of Event or Problem · 0

    IT WAS REPORTED THE WORKING BEAM OF TWO FIBERS WERE FIRING FORWARD FROM THE BEGINNING OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A THIRD FIBER. THERE WAS NO HARM TO THE PATIENT. THIS REPORT IS FOR THE FIRST FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIBER ONLY FIRED FORWARD. NO INFORMATION WAS PROVIDED ON HOW THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028876 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. 0010-2400 0022277294

    Patients

    Seq Age Sex Outcome Treatment
    1