BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 2171414 · Received June 30, 2011

    Report

    Report Number
    2028159-2011-00750
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    May 30, 2011
    Report Date
    May 31, 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
    OTHER

    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 NURSE REPORTED THAT DURING SURGERY, A SYSTEM MESSAGE WAS DISPLAYED. THE SYSTEM WAS REBOOTED AND THE SYSTEM MESSAGE PERSISTED. THE SURGEON DETERMINED THAT THE ASPIRATION WAS WEAK. THE CASE WAS CANCELLED, HOWEVER, THE PATIENT HAD ALREADY RECEIVED LOCAL ANESTHETIC BLOCK. THERE WAS NO HARM TO THE PATIENT REPORTED.

    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 UNK