BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L9000 LIGHTSOURCE

    MDR report key: 1893833 · Received November 1, 2010

    Report

    Report Number
    2936485-2010-00808
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    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 PRODUCT FLICKERED INTERMITTENTLY DURING PROCEDURES. IT WAS FURTHER REPORTED THAT THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES TO PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L9000 LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK