BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM

    MDR report key: 1940063 · Received December 22, 2010

    Report

    Report Number
    2028159-2010-02472
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    MPA
    PMA / PMN Number
    K951627
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEERING TECHNICIAN REPORTED THE SYSTEM SHUT DOWN ON ITS OWN AFTER DISPLAYING A SYSTEM MESSAGE IN THE MIDDLE OF A CASE. THE PROCEDURE WAS COMPLETED. ADD'L INFO RECEIVED FROM THE TECHNICIAN INDICATED AN ILLUMINATOR WAS USED FROM A SECOND SYSTEM IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO PT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM ENDOILLUMINATOR MPA ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1