BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1844214 · Received September 13, 2010

    Report

    Report Number
    2937094-2010-00365
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    November 24, 2009
    Report Date
    January 11, 2010
    Manufacturer
    AMS INNOVATION CENTER-SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION OBTAINED FROM THE CUSTOMER, AN AMS QUALITY SYSTEMS SPECIALIST AND MGR DETERMINED THAT THIS EVENT WAS NOT A COMPLAINT. THEREFORE, A DEVICE ANALYSIS WAS NOT PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2009 THE FIBER BROKE AT 126,048 JOULES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS INNOVATION CENTER-SILICON VALLEY NA 927R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other