BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X7000 XENON LIGHTSOURCE

    MDR report key: 1963287 · Received January 6, 2011

    Report

    Report Number
    2936485-2011-00004
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGEDLY, UNIT OVERHEATED AND SHUT OFF THE COUNTER INDICATED THAT IT HAS 200 PLUS HOURS OF SERVICE THOUGH THE BULB WAS RECENTLY REPLACED. IT WAS FURTHER REPORTED, THAT THE COUNTER MUST BE OFF.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK