BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X8000 BULB MODULE

    MDR report key: 2133204 · Received May 9, 2011

    Report

    Report Number
    2936485-2011-00295
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 DURING A CASE, THERE WAS A POP AND THE LIGHT SHUT OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X8000 BULB MODULE BULB FCW STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK