BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREENLIGHT ADDSTAT

    MDR report key: 2081101 · Received April 14, 2011

    Report

    Report Number
    2937094-2011-00687
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 29, 2011
    Manufacturer
    AMS, INNOVATION CTR - SILICON VALLEY
    Product Code
    GEX
    PMA / PMN Number
    K100746
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER ON (B)(6) 2011, THE FIBER CAP DETACHED AT 39,600 JOULES. ALSO, IT WAS REPORTED THAT THE FIBER CAP WAS RETRIEVED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENLIGHT ADDSTAT SURGICAL FIBER GEX AMS, INNOVATION CTR - SILICON VALLEY NA 103A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other