BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2022086 · Received February 28, 2011

    Report

    Report Number
    2937094-2011-00228
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 17, 2011
    Report Date
    February 1, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, 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

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, ENERGY WAS SHOOTING OUT OF THE FIBER TIP VERSUS OUT AT AN ANGLE AT 11,000 JOULES. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY NA 027H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other