BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1843967 · Received September 13, 2010

    Report

    Report Number
    2937094-2010-00151
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    March 25, 2010
    Report Date
    June 1, 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
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER BROKE AT THE CAP AT 50,000 JOULES. THE CAP WAS SUBSEQUENTLY RETRIEVED AND NO PATIENT INJURY WAS REPORTED. THE DEVICE WAS RETURNED FOR EVALUATION. A FAILURE ANALYSIS REPORT IS PENDING.

    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 943T

    Patients

    Seq Age Sex Outcome Treatment
    1