BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 3072616 · Received April 19, 2013

    Report

    Report Number
    2028159-2013-00737
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 25, 2013
    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 REPLICATED THE SYSTEM MESSAGE REPORTED. THE LOW PRESSURE AIRE SOURCE MANIFOLD ASSEMBLY WAS REPLACED. 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. A REVIEW OF COMPLAINTS FOR THE LAST (B)(4) DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE EQUIPMENT DISPLAYED A SYSTEM MESSAGE AND LOCKED DURING A VITRECTOMY PROCEDURE. IT WAS ALSO REPORTED THAT LIQUID LEAKED INTO THE EQUIPMENT DURING THE FLUID/GAS EXCHANGE. THE EQUIPMENT WAS EXCHANGED AND THE CASE WAS COMPLETED AFTER A DELAY OF LESS THAN 15 MINUTES. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169185 ACCURUS 400VS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1