BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 2904039 · Received January 3, 2013

    Report

    Report Number
    2028159-2012-02057
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 1, 2012
    Report Date
    December 4, 2012
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CHARGE NURSE REPORTED THAT DURING A CATARACT/VITRECTOMY PROCEDURE, BSS (BALANCED SALT SOLUTION) COULD NOT FLOW FROM THE CASSETTE TO THE DRAIN BAG, CAUSING A BLOCKAGE OF THE INSTRUMENT. THE CASE WAS ABLE TO BE COMPLETED WITHOUT HARM TO THE PT. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3540 ACCURUS 800CS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCURUS ANTERIOR PAK W/O REFLUX BSC