BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT MOXY FIBER OPTIC

    MDR report key: 2902970 · Received December 26, 2012

    Report

    Report Number
    2937094-2012-01346
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 27, 2012
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED A CLINICAL STUDY PATIENT HAD A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE (B)(6) 2012. SIX MONTHS, NINE DAYS POST PROCEDURE, THE PATIENT PRESENTED WITH RETROGRADE EJACULATION, ONSET DATE (B)(6) 2012. NO FURTHER INFORMATION WAS REPORTED.

    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 206A

    Patients

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