BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENLIGHT HPS FIBER OPTIC

    MDR report key: 3072354 · Received April 18, 2013

    Report

    Report Number
    2937094-2013-00486
    Event Type
    Injury
    Date Received
    April 18, 2013
    Report Date
    March 1, 2013
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LETTER, MAN CLAIMS "THE GREENLIGHT SURGERY WAS NOT SUCCESSFUL AND I WAS TOLD THAT I WOULD HAVE TO RETRAIN MY BLADDER. MEDICATION FOR OVER A YEAR HAS NOT WORKED. I AM ON THE VERGE OF BEING INCONTINENT". REPORTEDLY, POST PROCEDURE CAT SCAN SHOWED AN ENLARGED PROSTATE. A DOCTOR PERFORMED THIS PROCEDURE IN (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166906 GREENLIGHT HPS FIBER OPTIC POWERED SURGICAL LASER INSTRUMENT GEX AMERICAN MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other