BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1834392 · Received September 10, 2010

    Report

    Report Number
    2028159-2010-01739
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 13, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT INVOLVEMENT" (NO PATIENT INVOLVEMENT). PRODUCT PROBLEM(S): "TIGHT TROCAR" (FITTING PROBLEM). A SURGEON REPORTED THE CANNULA COULD NOT FIT WITH THE TROCAR. THE SURGEON REPORTED, UPON MICROSCOPIC OBSERVATION, THE CANNULA GAUGE WAS FOUND TO BE THICK AND DEFORMED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 800CS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS 10019487X

    Patients

    Seq Age Sex Outcome Treatment
    1