BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X7000 XENON LIGHTSOURCE

    MDR report key: 2251639 · Received August 30, 2011

    Report

    Report Number
    2936485-2011-00640
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WILL NOT COME OFF STAND BY MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X7000 XENON LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK