BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION

    MDR report key: 2030937 · Received March 4, 2011

    Report

    Report Number
    2028159-2011-00230
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND REPLACED THE FLUIDICS MODULE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A SAMPLE WAS RETURNED FOR EVALUATION AND ANALYSIS. A VISUAL ASSESSMENT OF THE RETURNED FLUIDICS MODULE DID NOT REVEAL ANY NONCONFORMITIES. THE REPORT OF CASSETTE STUCK IN THE MODULE WAS UNABLE TO BE CONFIRMED AS THE MODULE WAS SENT BACK WITHOUT THE "STUCK" CASSETTE. THE REPORTED EVENTS OF THE SYSTEM GENERATING A MESSAGE AND "CASSETTE UNABLE TO EJECT" WERE UNABLE TO BE CONFIRMED NOR REPLICATED THROUGH FUNCTIONAL TESTING; THE FLUIDICS MODULE MET SPECIFICATIONS. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DURING FIRST PROCEDURE OF THE DAY, A SYSTEM MESSAGE ERROR DISPLAYED AND THE CASSETTE COULD NOT BE EJECTED. THE UNIT WAS REBOOTED SEVERAL TIMES, BUT THE MESSAGE PERSISTED. ANOTHER SYSTEM WAS USED TO COMPLETE THE SURGERY ON THE SAME DAY. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1