BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT BULB FOR X7000 (300 WATTS)

    MDR report key: 1881422 · Received October 19, 2010

    Report

    Report Number
    2936485-2010-00779
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 7, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LIGHTSOURCE UNIT DISPLAYED A BULB ERROR AND THE BULB WOULD NOT IGNITE FOLLOWING THE ADDITION OF A REPLACEMENT BULB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT BULB FOR X7000 (300 WATTS) X7000 BULBS FCW STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK