BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L9000 LIGHTSOURCE INTERNATIONAL KIT

    MDR report key: 1915331 · Received November 17, 2010

    Report

    Report Number
    2936485-2010-00856
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE UNIT WAS TURNED ON, AN E-4 ERROR MESSAGE APPEARED ON THE SCREEN AND THE UNIT DID NOT FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L9000 LIGHTSOURCE INTERNATIONAL KIT LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE 10H058044

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK