BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 2181435 · Received July 6, 2011

    Report

    Report Number
    2028159-2011-00759
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Report Date
    June 6, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND VERIFIED SYSTEM MESSAGE "VFI (INJECT) AND PROP SCISSORS ARE NOT AVAILABLE" IN THE SYSTEM'S EVENT LOG. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT CAUSE IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    A NURSE COORDINATOR REPORTED THAT ON OCCASION, THE SYSTEM DISPLAYS AN ERROR MESSAGE WHEN BEGINNING THE FLUID / GAS EXCHANGE. THE ISSUE RESOLVES AFTER REBOOTING THE SYSTEM IN MOST CASES; HOWEVER, DURING ONE CASE, THE ISSUE PERSISTED AND THE SURGEON PERFORMED THE FLUID / GAS EXCHANGE MANUALLY. THERE WAS NO INJURY OR HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 400VS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1