BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1950287 · Received December 14, 2010

    Report

    Report Number
    2937094-2010-01293
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 10, 2010
    Report Date
    November 17, 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
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER WORKED AND SUDDENLY THERE WAS A BURNING SMELL AND THE TIP OF THE FIBER BURNED AT AN UNK AMOUNT OF JOULES. ALSO, IT WAS REPORTED THAT THE FIBER TIP (CAP) WAS NOT CLEANED DURING THE PROCEDURE.

    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 943K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other