BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM

    MDR report key: 2101744 · Received May 10, 2011

    Report

    Report Number
    2028159-2011-00518
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Report Date
    February 2, 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
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL ASSESSMENT OF THE RETURNED SAMPLE DID NOT REVEAL ANY NONCONFORMITY. THE REPORTED EVENT WAS CONFIRMED ON THE SYSTEM EVENT LOG AND REPLICATED BY THE REPAIR SHOP. THE ASSEMBLY (ASSY), PRINTED CIRCUIT BOARD (PCB), FRONT PANEL VITREOUS HIGH BRIGHTNESS ILLUMINATOR (VHBI), AND THE CONNECTOR GASKETS AS WELL AS THE SMART PCB GASKET WERE REPLACED BY THE REPAIR SHOP TO CORRECT THE REPORTED EVENT. THE ASSY, PCB, FRONT PANEL VHBI UNDERWENT FUNCTIONAL TESTING, BUT THE REPORTED EVENT WAS NOT REPLICATED. THE ASSY, PCB, FRONT PANEL VHBI WAS FOUND TO MEET SPECIFICATIONS. A REVIEW OF COMPLAINTS AND SERVICE REQUESTS FOR THE LAST 24 MONTHS INDICATED NO ADDITIONAL, RELATED REPORTS FOR THIS SYSTEM. THE ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING A SYSTEM MESSAGE DURING SURGERY. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED WITH NO PATIENT IMPACT.

    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