BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCURUS 800CS

    MDR report key: 1772219 · Received July 22, 2010

    Report

    Report Number
    2028159-2010-01265
    Event Type
    Injury
    Date Received
    July 22, 2010
    Date of Event
    June 22, 2010
    Report Date
    June 22, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED SYSTEM MESSAGE. THERE WAS A BSS (BALANCED SALT SOLUTION) TRAIL ON THE RECEIVER MECHANISM BOARD. THE MECHANISM BOARD WAS REPLACED. THE 57 PSI PRESSURE WAS FOUND TO BE UNSTABLE. THE 57 PSI REGULATOR WAS REPLACED. THE L8 CUTTER SOLENOID AND CASSETTE SEAL WERE ALSO REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. SAMPLES WILL BE RETURNING FOR IN-HOUSE EVALUATION TO BE PERFORMED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS A NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4)

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "CASE WAS NOT ABLE TO BE COMPLETED" (NO CODE AVAILABLE). PRODUCT PROBLEM(S): "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). A NURSE REPORTED A SYSTEM MESSAGE APPEARED DURING A CASE. THE SYSTEM WAS NOT ABLE TO BE COMPLETED. THE SYSTEM WAS REBOOTED AND THE MESSAGE WAS NOT ABLE TO BE CLEARED. THERE WERE NO PATIENT INJURIES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 Other