BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2172168 · Received June 15, 2011

    Report

    Report Number
    2937094-2011-01220
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    December 11, 2010
    Report Date
    May 12, 2011
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO REGARDING THIS COMPLAINT WAS RECEIVED ON (B)(6) 2011 WHICH INDICATED THAT AN MDR WAS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2010 THE LASER BEAM FIRED STRAIGHT OUT OF THE FIBER AT 7,000 JOULES. PER THE CUSTOMER, THE END OF THE PROCEDURE WAS COMPLETED WITH TURP. 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 019H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other