BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 1840794 · Received September 17, 2010

    Report

    Report Number
    2028159-2010-01793
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 2010
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM. THERE WAS BSS NOTED IN THE HUB ROLLER AND UNDER THE FLUIDICS MODULE. THE REPRESENTATIVE REMOVED THE FLUIDICS MODULE AND CLEANED THE SENSORS AND PINCHERS. IT WAS ALSO NOTED THAT THE FOUR TABS OF THE PUMP WERE BLOCKED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE SURGEON WAS ABLE TO USE THE SYSTEM FOR THE LAST CASE OF THE DAY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING A SYSTEM MESSAGE DURING A PROCEDURE. THE EVENT OCCURRED AT THE END OF THE PROCEDURE WHEN THE CASSETTE WAS BEING PURGED. THE OPERATOR SWITCHED OFF THE SYSTEM AND TRIED TO REBOOT IT FOR THE NEXT PATIENT WITHOUT ANY SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED NOTING A SECOND SYSTEM WAS BROUGHT IN FOR THE REMAINING CASES OF THE DAY. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1