BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT XPS LASER SYSTEM

    MDR report key: 3820048 · Received May 20, 2014

    Report

    Report Number
    2937094-2014-00392
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)
    Product Code
    GEX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH HEMATURIA TWO WEEKS AFTER RECEIVING A GREENLIGHT PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT MOST LIKELY EXPERIENCED "SCABBING IN THE PROSTATIC URETHRA. THIS TISSUE / DEBRIS WAS VOIDED OUT APPROXIMATELY TWO WEEKS POST OP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300505 GREENLIGHT XPS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE) 0010-0210

    Patients

    Seq Age Sex Outcome Treatment
    1 Other