BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1844198 · Received September 13, 2010

    Report

    Report Number
    2937094-2010-00255
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 16, 2010
    Manufacturer
    AMS INNOVATION CENTER-SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER CAP DETACHED INSIDE THE PATIENT AT 797 JOULES. THE CAP WAS SUBSEQUENTLY RETRIEVED. NO PT INJURY OCCURRED. THE DEVICE WAS NOT RETURNED TO AMERICAN MEDICAL SYSTEMS FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS INNOVATION CENTER-SILICON VALLEY NA 940U

    Patients

    Seq Age Sex Outcome Treatment
    1 Other