BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1172223 · Received September 18, 2008

    Report

    Report Number
    2028159-2008-00347
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    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
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY BIOMEDICAL TECHNICIAN POWERED ON THE SYSTEM, AND VERIFIED THE ILLUMINATOR IS WORKING. THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM, AND COULD NOT CONFIRM THE REPORT. THE POWER SUPPLY WAS REPLACED, AND SENT FOR IN HOUSE TESTING. THE SYSTEM WAS TESTED, AND IT MET ALL PRODUCT SPECIFICATIONS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED, WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BURNING SMELL FROM BEHIND THE ILLUMINATOR. FIVE CASES WERE CANCELLED. THERE WAS NO PATIENT HARM 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 NI