BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION

    MDR report key: 2043088 · Received March 25, 2011

    Report

    Report Number
    2028159-2011-00292
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM REPORTED. A SYSTEM MESSAGE INDICATING THAT THE AUXILIARY ILLUMINATOR NEED TO BE REPLACED WAS FOUND IN THE EVENT LOG. THE AUXILIARY ILLUMINATOR MODULE WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE MANAGER REPORTED THAT AT THE BEGINNING OF A SURGICAL CASE, AFTER ENTERING THE EYE, THE SYSTEM DISPLAYED A MESSAGE INDICATING THERE WAS AN ASPIRATION LEVEL SENSOR PROBLEM DETECTED. THE SYSTEM WAS RESTARTED SEVERAL TIMES WITH THE SAME RESULT. THE SYSTEM WAS EXCHANGED AND THE CASE WAS COMPLETED AFTER A 30 MINUTE DELAY. THE PATIENT HAS EXPERIENCED NO COMPLICATIONS OR ADDITIONAL TREATMENT.

    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 UNK