BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1823671 · Received August 27, 2010

    Report

    Report Number
    2028159-2010-01614
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    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
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND CONFIRMED THE PROBLEM REPORTED. THE COMPANY SERVICE REP TESTED FOUR PHACO HANDPIECES AND FOUND THAT THE HANDPIECES WERE NON-CONFORMING. THE COMPANY SERVICE REP RECOMMENDED THE CUSTOMER REPLACE THE HANDPIECES. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "SYSTEM FROZE" (NO DISPLAY OR DISPLAY FAILURE). THE NURSE REPORTED THE SYSTEM FROZE TWICE DURING PHACO. THE SYSTEM WAS ATTEMPTED WAS REBOOTED TWICE, BUT IT FROZE AGAIN. THE SYSTEM WAS SWITCHED OUT TO COMPLETE THE CASE. NO PT INJURY 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 UNK