BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 3093775 · Received April 30, 2013

    Report

    Report Number
    2937094-2013-00536
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    July 24, 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

    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. TWENTY-FIVE DAYS POST PROCEDURE, THE PT PRESENTED WITH RETROGRADE EJACULATION, ONSET DATE (B)(6) 2012; CONTINUING AS OF (B)(6) 2012. NO FURTHER INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186606 GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS 0010-2400 138A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other