BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L9000 LIGHTSOURCE

    MDR report key: 2221408 · Received August 16, 2011

    Report

    Report Number
    2936485-2011-00594
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    GCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 UNIT DISPLAYED AN E-2 ERROR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK