BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 2180976 · Received July 7, 2011

    Report

    Report Number
    2028159-2011-00777
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 7, 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
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYSTEM. THE COMPANY REP EXAMINED THE SYSTEM AND TESTED ALL VACUUM FUNCTIONS AND FOUND THEM TO MEET SPECIFICATIONS. PREVENTATIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT THE VITRECTOR STOPPED WORKING AND WOULD NOT SUCTION DURING SURGERY. THE SYSTEM WAS EXCHANGED AND THE CASE WAS COMPLETED AFTER A 10-15 MIN DELAY. NO HARM TO THE PT WAS REPORTED.

    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