BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X8000 LIGHTSOURCE

    MDR report key: 1830134 · Received September 1, 2010

    Report

    Report Number
    2936485-2010-00688
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 25, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 DISPLAYING AN E-1 ERROR MESSAGE, INDICATING A POTENTIAL BALLAST FAULT. IT WAS FURTHER REPORTED THAT THE BULB FAILED TO IGNITE. THERE WERE NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X8000 LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE 09K050374

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK