BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X8000 LIGHTSOURCEQ

    MDR report key: 1991336 · Received January 26, 2011

    Report

    Report Number
    2936485-2011-00052
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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 THE UNIT DISPLAYED AN E-1 ERROR MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X8000 LIGHTSOURCEQ LIGHTSOURCE FCW STRYKER ENDOSCOPY 07J055474

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK