BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1834402 · Received September 10, 2010

    Report

    Report Number
    2028159-2010-01745
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 9, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A 23 GAUGE PROBE HAS BEEN RECEIVED 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). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 2010. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT INJURY" (NO CONSEQUENCES OR IMPACT TO PATIENT). PRODUCT PROBLEM(S): "CUTTING PROBLEM" (FAILURE TO CUT). A SURGEON REPORTED DISSATISFACTION REGARDING THE PROBE CUTTING. THE PROBE WAS SWITCHED OUT AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 800CS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS 10015039X

    Patients

    Seq Age Sex Outcome Treatment
    1