BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1930269 · Received November 18, 2010

    Report

    Report Number
    2937094-2010-01145
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 29, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE AIMING BEAM FIRED STRAIGHT OUT OF THE FIBER AND THE FIBER TIP DETACHED INSIDE OF THE PT AT 208,446 JOULES. ALSO, IT WAS REPORTED THAT THE FIBER TIP WAS FLUSHED FROM THE PT'S BLADDER. NO PT INJURY WAS REPORTED. THE DEVICE WAS NOT RETURNED FOR EVAL.

    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 028H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other