BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2963288 · Received February 12, 2013

    Report

    Report Number
    2937094-2013-00189
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    October 1, 2012
    Report Date
    January 31, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED A (B)(4) STUDY PT HAD BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE (B)(6) 2012. NINE MONTHS, SEVEN DAYS POST PROCEDURE, THE PT PRESENTED WITH RETROGRADE EJACULATION, ONSET DATE (B)(6) 2012; CONTINUING (B)(6) 2013. NO FURTHER INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62069 GREENLIGHT MOXY FIBER OPTIC POWER LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 152A

    Patients

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