BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 2043084 · Received March 25, 2011

    Report

    Report Number
    2028159-2011-00294
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Report Date
    February 23, 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
    UNKNOWN
    Health Professional
    *

    Narratives

    Additional Manufacturer Narrative · 1

    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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SYSTEM MESSAGE WAS DISPLAYED DURING SURGERY. THE SURGERY WAS CANCELED AFTER THE PATIENT HAD RECEIVED LOCAL ANESTHESIA. ADDITIONAL INFORMATION WAS REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED FROM A NURSE REPORTING DURING A VITRECTOMY PROCEDURE A SYSTEM MESSAGE DISPLAYED. THE SYSTEM WAS REBOOTED, BUT MESSAGE COULD NOT BE CLEARED. THE SYSTEM WAS SWITCHED OUT, AFTER A DELAY OF ONE HOUR, AND THE CASE WAS COMPLETED. THE CASE WAS NOT CANCELED AS WAS ORIGINALLY REPORTED AND THERE WAS NO HARM TO THE PATIENT.

    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