BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X8000 LIGHTSOURCE

    MDR report key: 2000648 · Received February 3, 2011

    Report

    Report Number
    2936485-2011-00073
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT EXPERIENCED AN E-1 ERROR. IT WAS NOT SURE IF THE EVENT HAPPENED PRIOR TO THE BEGINNING OF THE CASE OR IF IT HAPPENED IN THE MIDDLE OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X8000 LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE 06L032824

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK