BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM

    MDR report key: 2770163 · Received October 1, 2012

    Report

    Report Number
    2028159-2012-01484
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    August 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    MPA
    PMA / PMN Number
    K951627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE REPORTED PROBLEM. THE COMPANY REPRESENTATIVE REPLACED THE LAMP AND CLEANED THE FILTER. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. NO SAMPLES WERE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID INDICATE ONE SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THE XENON LAMP TURNED OFF DURING A PROCEDURE. THE LIGHT SYSTEM WAS SWITCHED OUT TO COMPLETE THE CASE. THERE WAS NO HARM TO THE PATIENT.

    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 UNK