BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 2222933 · Received August 10, 2011

    Report

    Report Number
    2028159-2011-00926
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 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
    BR
    Reporter Occupation
    UNKNOWN

    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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SYSTEM MESSAGE WAS DISPLAYED PRIOR TO BEGINNING A VITRECTOMY PROCEDURE. THE SURGEON PROCEEDED TO MAKE THE INCISION AND BEGAN THE PROCEDURE WITH THE KNOWLEDGE THAT HE WOULD NEED TO CHANGE SYSTEMS FOR THE GAS EXCHANGE. WHEN THE TIME CAME FOR THE GAS EXCHANGE TO BE PERFORMED, THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED. THERE WAS A 40 MINUTE DELAY REPORTED WHILE THE SYSTEM WAS BEING SWITCHED OUT. THERE WAS NO HARM TO THE PATIENT.

    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