BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM

    MDR report key: 3042899 · Received April 4, 2013

    Report

    Report Number
    2028159-2013-00624
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 8, 2013
    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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND PERFORMED AN INTERNAL AND EXTERNAL CLEANING OF THE EQUIPMENT. THE COMPANY REPRESENTATIVE CLEANED THE FILTERS AND MIRRORS. THE FAN FILTER WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. IT SHOULD BE NOTED THAT A DIRTY FAN FILTER CAN BLOCK THE AIR PATHWAYS CAUSING THE SYSTEM TO OVERHEAT AND SHUT DOWN. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST (B)(4) DID INDICATE 1 SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, A POTENTIAL ROOT CAUSE FOR THIS REPORTED EVENT WAS DETERMINED TO BE A DIRTY FAN FILTER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE ILLUMINATION SYSTEM TURNED OFF ON ITS OWN DURING A PROCEDURE. FOLLOWING A DELAY OF MORE THAN 15 MINUTES, THE PROCEDURE WAS COMPLETED WITH NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139116 ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM ENDOILLUMINATOR MPA ALCON - IRVINE TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1