BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1891072 · Received October 29, 2010

    Report

    Report Number
    2028159-2010-02119
    Event Type
    Malfunction
    Date Received
    October 29, 2010
    Date of Event
    September 30, 2010
    Report Date
    September 30, 2010
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND FOUND SALINE IN THE PRESSURE VACUUM MANIFOLD. THE PRESSURE VACUUM MANIFOLD WAS REPLACED TO CORRECT THE PROBLEM. THE REPLACED PART WILL BE SENT IN FOR IN-HOUSE EVALUATION. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A COMPANY SALES REPRESENTATIVE WAS NOTIFIED THAT A FLUID EGRESS HAD OCCURRED. AN INSERVICE WILL BE SCHEDULED SO THE SAME MISTAKE WILL NOT BE REPEATED. 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 SURGEON REPORTED WHEN HE ACTIVATED THE VISCOUS FLUID CONTROL (VFC) EXTRACT, THERE WAS NO EXTRACTION. THE SURGEON THEN SELECTED VFC INJECT AND AIR PRESSURE CAME OUT OF THE SCISSORS PORT. THE CASE WAS THEN COMPLETED BY MANUALLY INJECTING THE SILICONE OIL. THERE WAS NO PATIENT HARM, DELAY, OR CANCELLATIONS.

    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