BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2831647 · Received November 9, 2012

    Report

    Report Number
    2937094-2012-01224
    Event Type
    Injury
    Date Received
    November 9, 2012
    Date of Event
    April 12, 2012
    Report Date
    October 10, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - USED FOR RETROGRADE EJACULATION.

    Description of Event or Problem · 1

    IT WAS REPORTED A CLINICAL STUDY PT HAD A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE (B)(6) 2012. TWO MONTHS, THREE WEEK POST PROCEDURE, THE PT PRESENTED WITH RETROGRADE EJACULATION, CONTINUING AS OF (B)(6) 2012. NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 141A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACCESSORIES| GREENLIGHT XPS LASER SYSTEM