BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X8000 LIGHTSOURCE

    MDR report key: 2000643 · Received February 3, 2011

    Report

    Report Number
    2936485-2011-00072
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 21, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FCW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    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 POWER WAS APPLIED TO THE UNIT, AN E-3 ERROR APPEARED ON THE LCD AFTER 5-10 MINUTES. IT WAS FURTHER REPORTED THAT THE VOLTAGE ON THE TP13 WAS RUNNING LOW, BETWEEN .1 AND .5.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK