BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 2201668 · Received August 4, 2011

    Report

    Report Number
    2028159-2011-00900
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    February 1, 2011
    Report Date
    July 5, 2011
    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
    FR
    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 NURSE REPORTED THAT DURING SURGERY, AFTER THE PROBE HAD BEEN INSERTED INTO THE PT'S EYE, THE SYSTEM STOPPED WORKING. THEY TRIED REBOOTING WITHOUT SUCCESS. NOTHING APPEARED ON THE SCREEN AND ALL THE OUTLETS OF THE OPERATING ROOM HAD BLOWN. IN ORDER TO COMPLETE THE PROCEDURE, ANOTHER SYSTEM WAS BROUGHT IN AND USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO HARM TO THE PT WAS REPORTED. PT IDENTIFIERS WERE NOT DISCLOSED.

    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