BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1890844 · Received October 28, 2010

    Report

    Report Number
    2937094-2010-00921
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 1, 2010
    Manufacturer
    AMS, INNOVATION CTR - 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 BROKE AND THE FIBER TIP BURNED RESULTING WHICH LED TO A BURNING SMELL. THE AMOUNT OF JOULES EXPENDED WAS NOT PROVIDED. ALSO, IT WAS REPORTED THAT THE GLAND WAS VERY VASCULAR. THE FIBER WAS NOT CLEANED DURING THE PROCEDURE. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS, INNOVATION CTR - SILICON VALLEY NA 943K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other