BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X8000 LIGHTSOURCE

    MDR report key: 1821722 · Received August 25, 2010

    Report

    Report Number
    2936485-2010-00669
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 10, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SAFELIGHT LIGHTCABLE WAS USED, THE UNIT WOULD GO INTO STANDBY MODE INTERMITTENTLY THROUGHOUT THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X8000 LIGHTSOURCE LIGHTSOURCE FCW STRYKER ENDOSCOPY SAN JOSE 08C019714

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK