BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 2072405 · Received April 8, 2011

    Report

    Report Number
    2028159-2011-00344
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Report Date
    March 9, 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
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND COULD NOT DUPLICATE THE REPORTED EVENT. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THE CUSTOMER FEELS THAT THE ISSUE WAS RELATED TO THE USE OF THE 25 GAUGE TOTAL PLUS PAK (THEY HAVE BEEN USING THE REGULAR 25 GAUGE TOTAL PAK) AND THE STAFF WAS NOT AWARE THEY HAD TO CHANGE THE SETTING ON THE SYSTEM. THE STAFF IS NOW AWARE AND HAS USED THE SYSTEM WITH THE 25 GAUGE TOTAL PLUS PAK WITH NO ISSUES. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE OF THE REPORTED EVENT WAS USE MISHANDLING AS THE CUSTOMER WAS UNAWARE THAT THE SYSTEM SETTINGS HAD TO BE ADJUSTED TO USE THE TOTAL PAK PLUS. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE UNIT STOPPED ASPIRATING DURING SURGERY. THEY REPLACED THE CONSUMABLE, BUT STILL HAD ASPIRATION PROBLEMS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SURGEON WAS ABLE TO COMPLETE THE CASE DURING THE SAME PROCEDURE THOUGH IT IS NOT KNOWN WHAT WAS DONE. THE REPORTER INDICATED THAT THERE WAS NO PATIENT HARM OR INJURY, AND SHE THINKS THE ISSUE WAS RELATED TO USE OF A SPECIFIC PAK.

    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