BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 3043012 · Received March 7, 2013

    Report

    Report Number
    2028159-2013-00338
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED THE COMPANY REPRESENTATIVE TO ASSIST WITH TROUBLESHOOTING. THE COMPANY REPRESENTATIVE ORIENTED THE CUSTOMER, OVER THE TELEPHONE, TO ADJUST THE PRESSURE SUPPLIED TO THE SYSTEM; THIS RESOLVED THE CUSTOMER REPORTED EVENT. THE CUSTOMER DID NOT REQUEST SERVICE FOR THE SYSTEM. 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. WHILE IT IS NOT ENTIRELY CONCLUSIVE, BASED ON THE INFORMATION, THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS THAT THE PRESSURE SUPPLIED TO THE SYSTEM WAS LOW. ORIENTING THE CUSTOMER TO INCREASE THE PRESSURE SUPPLIED TO THE SYSTEM ADDRESSED THE CUSTOMER REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE SYSTEM DISPLAYED PROBLEMS WITH THE VACUUM DURING A PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME SYSTEM AND ACCESSORIES. THERE WAS NO PT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98512 ACCURUS 400VS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1