BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2043543 · Received March 28, 2011

    Report

    Report Number
    2937094-2011-00457
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 1, 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

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THE FIBER TIP BURNED AND MELTED AT 93,690 JOULES. ALSO, IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. 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 025H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other