BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES TWENTY THOUSAND LEGACY

    MDR report key: 851532 · Received May 16, 2007

    Report

    Report Number
    2028159-2007-00252
    Event Type
    Malfunction
    Date Received
    May 16, 2007
    Date of Event
    April 16, 2007
    Report Date
    April 16, 2007
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REP REPLACED THE FLUIDICS MODULE, COMPLETED A SYSTEM PM, AND THE SYSTEM MET SPECIFICATIONS. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. THIS REPORT MAILED IN TO FDA ON: 05/16/2007.

    Description of Event or Problem · 1

    A NURSE REPORTS, THAT THE UNIT FAILED TO PRIME AT THE BEGINNING OF SURGERY, PRIOR TO INCISION, RESULTING IN THE CANCELLATION OF 3 CASES. IT WAS FURTHER STATED, THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR