BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 400VS

    MDR report key: 2800749 · Received October 17, 2012

    Report

    Report Number
    2028159-2012-01597
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 20, 2012
    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
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND FOUND LIQUID/OIL IN THE PRESSURE VACUUM MANIFOLD ASSEMBLY. THE COMPANY REPRESENTATIVE NOTICED THERE WERE INDICATIONS THAT THE ISSUE OCCURRED DURING THE HANDLING OF THE STOPCOCK HANDLE. THE COMPANY REPRESENTATIVE REPLACED THE PRESSURE VACUUM MANIFOLD ASSEMBLY. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. NO SAMPLES WERE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION WAS PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE SYSTEM DISPLAYED AN ERROR MESSAGE AND LOCKED DURING A CATARACT EXTRACTION PROCEDURE. THE PROCEDURE WAS COMPLETED USING MANUAL TECHNIQUE WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 400VS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1