BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM

    MDR report key: 2181011 · Received July 7, 2011

    Report

    Report Number
    2028159-2011-00781
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    MPA
    PMA / PMN Number
    K951627
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE LIGHT SOURCE WENT OUT DURING SURGERY. WHEN THIS OCCURRED, THEY STABILIZED THE EYE, SHUT THE LIGHT SOURCE DOWN AND WAITED A FEW MINS. THE LIGHT DID NOT COME BACK ON. THEN THEY SHUT IT DOWN, UNPLUGGED, AND REPLUGGED IT, AND IT DID NOT COME BACK ON. THE PROCEDURE WAS COMPLETED WITH THE SYSTEM LIGHT SOURCE, AND THERE WAS NO HARM TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM ENDOILLUMINATOR MPA ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK