BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 2211679 · Received August 5, 2011

    Report

    Report Number
    2028159-2011-00910
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 8, 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 COULD NOT DUPLICATE THE CUSTOMER REPORTED EVENT. THE COMPANY REPRESENTATIVE CLEANED THE CASSETTE RECEPTACLE AND ID PLATE. THE SYSTEM WAS THEN TESTED AND MET PRODUCT SPECIFICATIONS. NO SAMPLES WERE RETURNED FOR EVALUATION AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT CAUSE IS UNK. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING SURGERY, THE EQUIPMENT AND THE FOOTSWITCH STOPPED WORKING. THE SURGEON EXCHANGED SEVERAL CASSETTES AND WAS ABLE TO PROCEED AND COMPLETE THE SURGERY WITH THE SAME CONSOLE. THERE WAS A DELAY OF APPROX AN HOUR WHILE THE TROUBLESHOOTING WAS ACCOMPLISHED. NO HARM TO THE PT WAS REPORTED.

    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