BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM

    MDR report key: 1823649 · Received August 27, 2010

    Report

    Report Number
    2028159-2010-01622
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Report Date
    July 30, 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
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM HAS BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY WAS REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). THE CUSTOMER REPORTED THAT DURING SURGERY THE LIGHT WENT OUT. ADDITIONAL INFO RECEIVED FROM THE NURSE STATED THE LIGHT WENT OUT DURING SURGERY. THE SYSTEM WAS REBOOTED AND THE LIGHT RETURNED. ABOUT 15 MINUTES LATER THE LIGHT WENT OUT AGAIN. THE SYSTEM WAS REBOOTED AND THE LIGHT RETURNED. A SYSTEM MESSAGE THAN DISPLAYED AND COULD NOT BE CLEARED. THE LIGHT SOURCE WAS SWITCHED OUT TO COMPLETE THE CASE. NO PT INJURY WAS 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