BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2180888 · Received July 7, 2011

    Report

    Report Number
    2937094-2011-01434
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 21, 2011
    Manufacturer
    AMS, INNOVATION CENTER-SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THE FIBER BROKE DURING THE PROCEDURE AT 134,165 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 035H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other