BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L9000 LIGHT SOURCE

    MDR report key: 1810943 · Received August 10, 2010

    Report

    Report Number
    2936485-2010-00609
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNIT GIVES AN E3 ERROR. LED LIGHT WON'T COME OFF STANDBY. MAKES SCREECHING NOISE WHILE RUNNING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK