BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1973781 · Received January 17, 2011

    Report

    Report Number
    2937094-2010-01567
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 23, 2010
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010 THERE WERE STONES IN THE PROSTATE AT 108,744 JOULES. IT IS UNK AT THE TIME IF STONES IN PROSTRATE CAUSED THE FIBER FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY NA 027H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other