BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 1070132 · Received July 3, 2008

    Report

    Report Number
    2028159-2008-00240
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 3, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND REPLACED THE POWER SUPPLY. THE SYSTEM WAS TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE COMPANY SERVICE REPRESENTATIVE ALSO TESTED TWO FOOTSWITCHES AND FOUND THE SURGEON CONTROL WAS NOT FUNCTIONING ON THE FOOTSWITCHES. THE CUSTOMER STATED THEY WOULD ORDER REPLACEMENT FOOTSWITCHES. THE POWER SUPPLY WAS SENT IN FOR IN-HOUSE TESTING. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THIS REPORT MAILED IN TO FDA ON: 07/03/2008.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM PRIMED AND TUNED FOR THE PROCEDURE. WHEN THE CUSTOMER PLACED THE FOOTSWITCH ON THE FLOOR, AN ERROR MESSAGE WAS NOTED FOR 24V FLUIDICS FAILURE. THE CUSTOMER SWITCHED OUT THE FOOTSWITCH, BUT STILL RECEIVED THE SAME ERROR MESSAGE. THE CASE WAS CANCELLED. FURTHER INFORMATION RECEIVED STATED THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES TWENTY THOUSAND LEGACY OPHTHALMIC SURGERY SYSTEM HQE ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI