BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT MOXY

    MDR report key: 2228834 · Received August 15, 2011

    Report

    Report Number
    2937094-2011-01672
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 20, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 THE FIBER DID NOT WORK BUT MADE THE LASER SWITCH TO STAND BY FOUR TIMES AT 45,002 JOULES. PER AN AMERICAN MEDICAL SYSTEMS REPRESENTATIVE, ADVISED THAT THE LASER INDICATED THE FIBER OVERHEATED AND THEN WENT INTO STAND BY. PER THE CUSTOMER, AFTER THE FOUR ATTEMPTS THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE FIBER. THE PATIENT OUTCOME WAS NOT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT MOXY SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY NA 103A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other