BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L9000 LIGHT SOURCE

    MDR report key: 2896754 · Received November 21, 2012

    Report

    Report Number
    2936485-2012-00561
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    PMA / PMN Number
    K082813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    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 DURING A PROCEDURE, THE LIGHT SOURCE UNIT WENT FROM ACTIVE TO STANDBY AND BACK TO ACTIVE MODE ON ITS OWN. IT WAS FURTHER REPORTED THAT THIS HAPPENED SEVERAL TIMES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK