BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X8000 LIGHTSOURCE

    MDR report key: 1941004 · Received December 8, 2010

    Report

    Report Number
    2936485-2010-00913
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 DURING A CASE, THE UNIT WOULD NOT TURN BACK ON WHEN PROMPTED. THE UNIT WAS TURNED BACK OFF AND ON AND IT DID NOT WORK. THE LIGHT WAS DOWN TO ZERO. IT WAS FURTHER REPORTED THAT THIS HAPPENED A COUPLE OF TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X8000 LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE 08J005094

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK