BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 2860015 · Received December 4, 2012

    Report

    Report Number
    2028159-2012-01850
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 5, 2012
    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
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE REEXAMINED THE SYSTEM AND WAS ABLE TO CONFIRM THE REPORTED EVENT. THE COMPANY REPRESENTATIVE REPLACED THE HUB ROLLER ASSEMBLY TO ADDRESS THE REPORTED EVENT. THE SYSTEM WAS THEN TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. NO SAMPLE WERE RETURNED FOR EVALUATION. 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 OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED CASSETTE LOADING PROBLEMS DURING SURGERY. THE PROCEDURE WAS CANCELLED WITH NO PATIENT HARM.

    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