BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1844030 · Received September 13, 2010

    Report

    Report Number
    2937094-2010-00092
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    January 17, 2010
    Report Date
    April 6, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER BROKE OR CRACKED AT 113,695 JOULES. NO INJURY WAS REPORTED. THE DEVICE WAS NOT RETURNED TO AMS FOR EVALUATION.

    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 941C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other