BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT PV ADDSTAT

    MDR report key: 2172186 · Received June 15, 2011

    Report

    Report Number
    2937094-2011-01212
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 19, 2011
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K010284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011 THE FIBER BROKE IN THE MIDDLE OUTSIDE OF THE PT AT 27,686 JOULES. NO PT INJURY WAS REPORTED. ALSO, NO CUSTOMER INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT PV ADDSTAT SURGICAL FIBER GEX AMS, INNOVATION CENTER - SILICON VALLEY NA 937P

    Patients

    Seq Age Sex Outcome Treatment
    1 Other