BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION

    MDR report key: 1983101 · Received February 4, 2011

    Report

    Report Number
    2028159-2011-00080
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE PROBLEM REPORTED. THE SYSTEM MESSAGE REPORTED WAS OBSERVED. THE COMPANY REP RELOADED APPLICATION SOFTWARE. CABLES WERE RESEATED TO ALL OF THE MODULES, THE SUPERVISOR, HOST, AND THE HARD DRIVE. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. A ROOT CAUSE HAS NOT BEEN IDENTIFIED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING A SYSTEM MESSAGE DURING A VITRECTOMY AND RETINAL REPAIR PROCEDURE. THE SYSTEM'S POWER WAS CYCLED AND ONLY THE SCREEN DISPLAYED. A BACKUP SYSTEM WAS BROUGHT IN TO COMPLETE THE PROCEDURE. HOWEVER DURING SET UP, A MESSAGE APPEARED AND THE CUSTOMER WAS UNABLE TO CLEAR. THE SURGEON WAS UNABLE TO COMPLETE THE PROCEDURE AS PLANNED AND A SECONDARY PROCEDURE WAS PERFORMED THE FOLLOWING DAY. THE SURGEON IS UNSURE IF ANY ADD'L SURGERY WILL BE REQUIRED. THE PT'S CONDITION IS NOTED AS "GUARDED." THIS REPORT IS TO DOCUMENT THE EVENTS RELATED TO THE FIRST SYSTEM THAT WAS EXCHANGED. A SEPARATE REPORT HAS BEEN FILED TO DOCUMENT THE EVENT RELATED TO THE SECOND SYSTEM. ADD'L INFO 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 Required Intervention