BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 800CS

    MDR report key: 1993694 · Received February 11, 2011

    Report

    Report Number
    2028159-2011-00127
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS BEEN RECEIVED BY THE MANUFACTURER, BUT THE ANALYSIS HAS NOT BEEN COMPLETED. INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT NOISE OCCURRED DURING THE ULTRASOUND PORTION OF SURGERY AND THE CONSOLE STOOD STILL WITH A SYSTEM MESSAGE DISPLAYED. THE SYSTEM WAS REBOOTED, BUT IT COULD NOT RECOVER. THE SURGEON CONVERTED THE SURGERY METHOD AND WAS ABLE TO FINISH AFTER A FEW MINUTES DELAY. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 800CS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention