BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1913721 · Received November 12, 2010

    Report

    Report Number
    2028159-2010-02199
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    June 6, 2010
    Report Date
    August 17, 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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBE HAS BEEN REC'D AND IN-HOUSE TESTING IS IN PROGRESS. 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 CUSTOMER REPORTED THE PROBE WOULD NOT ASPIRATE OR CUT DUE TO CLOGGED TUBING AND THE INABILITY TO PRIME THE CASSETTE. THE CASSETTE AND TUBING WERE SWITCHED OUT AND THE ISSUE WAS RESOLVED. THERE WAS NO PT INVOLVEMENT AS THESE EVENTS OCCURRED DURING THE PRIMING PROCESS.

    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