BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400 VS

    MDR report key: 1711551 · Received May 26, 2010

    Report

    Report Number
    2028159-2010-00707
    Event Type
    Malfunction
    Date Received
    May 26, 2010
    Report Date
    April 5, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSE REQUESTED THE COMPANY SALES REPRESENTATIVE OBSERVE SURGERY AND ADDRESS THE PROBLEM WITH REFLUX REPORTED. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B) (4). (B) (4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INVOLVEMENT WAS REPORTED" (NO PT INVOLVEMENT). PRODUCT PROBLEM(S): "NO REFLUX WAS AVAILABLE" (REFLUX WITHIN DEVICE). THE NURSE REPORTED NO REFLUX WAS AVAILABLE. ADDITIONAL INFO RECEIVED FROM THE NURSE STATED THE SURGEONS ARE VERY FAMILIAR WITH THE SYSTEM AND ARE UNHAPPY WITH THE SYSTEM REFLUX PERFORMANCE. THE NURSE DECLINED TO COMPLETE THE QUESTIONNAIRE, AS THE REPORTED EVENT DID NOT OCCUR DURING SURGERY. THE SERVICE REQUEST WAS TO HAVE THE SYSTEM RECHECKED. NO PT INVOLVEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK