BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM

    MDR report key: 1891034 · Received October 22, 2010

    Report

    Report Number
    2028159-2010-02033
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS RETURNED FOR EVAL. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER REPORTED THE LIGHT SOURCE KEEPS SHUTTING DOWN. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED. THERE WAS NO PT IMPACT, DELAYS OR CANCELLATIONS 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