BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L9000 LIGHTSOURCE

    MDR report key: 1963313 · Received January 6, 2011

    Report

    Report Number
    2936485-2011-00006
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WILL NOT COME OFF OF STANDBY MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L9000 LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE 10K066614

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK