BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1840796 · Received September 17, 2010

    Report

    Report Number
    2028159-2010-01784
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Report Date
    August 19, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY CALLED IN TO TECHNICAL SERVICES AND A NEW FOOTPEDAL AND CABLE WERE ORDERED. THE REPLACED FOOTPEDAL WILL BE RETURNED FOR IN HOUSE INVESTIGATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED DURING A CASE A SYSTEM MESSAGE OCCURRED TWICE. AFTER THE FIRST SYSTEM MESSAGE WAS DISPLAYED, THE SYSTEM WAS REBOOTED AND THE MESSAGE WAS CLEARED. THE SECOND SYSTEM MESSAGE OCCURRED DURING IRRIGATION/ASPIRATION (I/A). THE NURSE WAS ABLE TO MANEUVER THROUGH THE REMAINDER OF THE CASE VIA THE TOUCHSCREEN. THERE WAS A 10 MINUTE DELAY IN SURGERY. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1