BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 1880038 · Received October 13, 2010

    Report

    Report Number
    2937094-2010-00717
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 14, 2010
    Manufacturer
    AMS, INNOVATION CENTER - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K062719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT ON (B)(6) 2010, THE FIBER CAP DETACHED AT 122,791 JOULES. ALSO, IT WAS REPORTED THAT THE FIBER CAP WAS RETRIEVED. NO PATIENT INJURY WAS REPORTED AND THE PATIENT OUTCOME WAS SUCCESSFUL. THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS, INNOVATION CENTER - SILICON VALLEY NA 015T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other