BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1950099 · Received December 7, 2010

    Report

    Report Number
    2028159-2010-02318
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 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
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBE IS BEING RETURNED FOR IN-HOUSE TESTING. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED INTERMITTENT CUTTER PERFORMANCE ISSUES RESULTING IN A DELAY IN PROCEDURE. THERE WAS NO PT INJURY REPORTED. ADD'L INFO WAS RECEIVED BY THE NURSE INDICATING AT THE BEGINNING OF A POSTERIOR VITRECTOMY PROCEDURE, THE CUTTER WOULD NOT WORK. THE PROBE WAS EXCHANGED AND THE CASE WAS COMPLETED WITHOUT FURTHER INCIDENTS.

    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