BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X8000 LIGHTSOURCE

    MDR report key: 1963493 · Received January 11, 2011

    Report

    Report Number
    2936485-2011-00018
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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 WAS HAVING PROBLEMS GOING BACK AND FORTH FROM STANDBY TO ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X8000 LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE 08C015624

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK