BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X6000 XENON LIGHTSOURCE

    MDR report key: 1821769 · Received August 26, 2010

    Report

    Report Number
    2936485-2010-00673
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 12, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 WHEN THE BULB WAS TAKEN OUT OF THE BOX AND INSTALLED IN THE LIGHTSOURCE, THE BULB DID NOT FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X6000 XENON LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK