BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1791285 · Received August 6, 2010

    Report

    Report Number
    2028159-2010-01405
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Report Date
    July 8, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VITRECTOMY PROBES HAVE 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 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PATIENT INVOLVEMENT" (NO PATIENT INVOLVEMENT). PRODUCT PROBLEM(S): "CUTTER NOT WORKING" (FAILURE TO CUT). THE NURSE REPORTED THE VITRECTOMY PROBES WERE NOT WORKING. THE ISSUE WAS NOTED DURING SET UP. THE PROBES WERE SWITCHED OUT AND THE CASE PROCEEDED. NO PATIENT INVOLVEMENT WAS REPORTED.

    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 UNK