BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L9000 LIGHTSOURCE

    MDR report key: 2190634 · Received July 27, 2011

    Report

    Report Number
    2936485-2011-00539
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT DISPLAYED AN E-2 ERROR MESSAGE. IT WAS FURTHER REPORTED THAT THIS HAPPENED DURING A CASE. FURTHER, THERE WAS A 5 MINUTE DELAY WITH NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION NEEDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK