BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2172174 · Received June 15, 2011

    Report

    Report Number
    2937094-2011-01219
    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 FIBER TIP BURNED AT 338,814 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 012H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other