BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2831227 · Received November 6, 2012

    Report

    Report Number
    2937094-2012-01187
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    May 23, 2012
    Report Date
    October 8, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 ON (B)(6) 2012. FOUR MONTHS, THREE WEEKS POST PROCEDURE, THE PT PRESENTED WITH RETROGRADE EJACULATION, ONSET DATE (B)(6) 2012; CONTINUING AS OF (B)(6) 2012. NO FURTHER INFORMATION 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 130A

    Patients

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