BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L9000 LIGHTSOURCE

    MDR report key: 1911364 · Received November 23, 2010

    Report

    Report Number
    2936485-2010-00880
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHT FLICKERS ON AND OFF. IT WAS FURTHER REPORTED THAT SOMETIMES THE LIGHT DOES NOT COME ON. THIS HAS HAPPENED IN MULTIPLE CASES AND HAS CAUSED MINOR DELAYS (E.G., 5 MINUTES). THERE WERE NO REPORTS OF ANY HARM TO ANY PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L9000 LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE 10G002714

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK