BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 800CS

    MDR report key: 1051105 · Received May 22, 2008

    Report

    Report Number
    2028159-2008-00188
    Event Type
    Injury
    Date Received
    May 22, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ALCON-IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND FOUND THE SYSTEM MET ALL PRODUCT SPECIFICATIONS ON ARRIVAL. NO ERROR MESSAGES WERE FOUND IN THE ERROR LOG. THE PRESSURE/VACUUM MANIFOLD AND ALL INTERNAL TUBING WERE VISUALLY INSPECTED FOR FLUID AND NO FLUID WAS OBSERVED. THE SERVICE TEST PROCEDURE WAS COMPLETED AND THE SYSTEM MET ALL PRODUCT SPECIFICATIONS. THE REPORTER DID NOT IDENTIFY TASS, BUT ALCON HAS CLASSIFIED THIS TYPE OF EVENT AS POTENTIALLY TASS. THE ROOT CAUSE OF THE PATIENT EVENT CANNOT BE DETERMINED IN THIS INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PATIENT PRESENTED WITH ENDOPHTHALMITIS TWO WEEKS AGO AND LOST HER SIGHT TOTALLY. THE PATIENT HAD LIGHT PERCEPTION PRE-OP, BUT NOW HAS NOTHING. THE SURGEON THINKS THE FLUID IN THE LINE (IN THE SYSTEM) SOMEHOW WAS NOT STERILE. MULTIPLE ATTEMPTS WERE MADE FOR MORE INFORMATION ON THE EVENT AND PATIENT STATUS WITH NO RESPONSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other