BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X8000 LIGHTSOURCE

    MDR report key: 1930488 · Received November 30, 2010

    Report

    Report Number
    2936485-2010-00895
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 GAVE AN E-1 ERROR DURING A CASE. THE UNIT WAS SWAPPED OUT, CAUSING A SLIGHT DELAY IN THE CASE. IT WAS FURTHER REPORTED THAT THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X8000 LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE 07A040864

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK