BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1832018 · Received September 3, 2010

    Report

    Report Number
    2028159-2010-01697
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Report Date
    August 5, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT HARM" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "BSS IS NOT PROPERLY DRAINED INTO THE BAG, AUTOMATIC PURGE DURING SURGERY" (DEVICE OPERATES DIFFERENTLY THAN EXPECTED). A BIOMEDICAL TECH REPORTED AN INTERMITTENT DRAINING OF THE BSS FROM THE INTERN CHAMBER TO THE BAG. ONCE THE CASSETTE WAS PURGED, THE SURGEON WAS ABLE TO RESUME THE PROCEDURE. THERE WAS NO PT HARM.

    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