BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION

    MDR report key: 2101991 · Received May 18, 2011

    Report

    Report Number
    2028159-2011-00534
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 18, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM, CONFIRMED THE CUSTOMER REPORTED EVENT, AND REPLACED THE PNEUMATIC MODULE. THE SYSTEM WAS THEN TESTED AND MET 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 SURGEON REPORTED THAT THE SYSTEM DISPLAYED AN ERROR CODE DURING SET UP FOR A VITRECTOMY PROCEDURE. THE PATIENT HAD RECEIVED SEDATION AND ANESTHESIA WHEN THE DOCTOR CANCELED THE CASE. THERE WAS NO HARM OR INJURY TO THE PATIENT.

    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