BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1891068 · Received October 29, 2010

    Report

    Report Number
    2028159-2010-02102
    Event Type
    Malfunction
    Date Received
    October 29, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WILL BE RETURNING FOR EVALUATION. 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 THAT HE NOTED SMALL METALLIC PARTICLES COMING OUT OF THE MOUTH OF THE VITRECTOMY CUTTER ONCE IT WAS IN THE EYE AND THE CUTTER WAS ENGAGED. HE STATED THAT HE SEES THIS OCCUR IN 1/10 CASES. A COMPANY'S SALES REPRESENTATIVE WAS PRESENT AT THE TIME OF SURGERY AND DID VISUALIZE THE METALLIC LOOKING PARTICLES. ADDITIONAL INFORMATION WAS REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED STATING PATIENT IDENTIFIERS WERE UNABLE TO BE OBTAINED. THE CASSETTE WAS NOT RETAINED FOR EVALUATION; ONLY THE CUTTER WAS RETAINED. THE FACILITY ALSO REPORTED THERE WAS NO "BUMPING" OF THE CUTTER AGAINST THE ILLUMINATOR OBSERVED.

    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