BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT XPS LASSER SYSTEM

    MDR report key: 4181381 · Received September 12, 2014

    Report

    Report Number
    2937094-2014-03096
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    June 3, 2012
    Report Date
    October 22, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    PMA / PMN Number
    K092735
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    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. TWENTY FOUR DAYS POST PROCEDURE, THE PT PRESENTED WITH RETROGRADE EJACULATION, ONSET DATE (B)(6) 2012. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564285 GREENLIGHT XPS LASSER SYSTEM POWERED LASER SURGICAL INSTRUMETN GEX AMERICAN MEDICAL SYSTEMS 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1 Other