BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM

    MDR report key: 2801410 · Received October 18, 2012

    Report

    Report Number
    2028159-2012-01621
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    MPA
    PMA / PMN Number
    K951627
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYS AND REPLACED THE XENON LAMP. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYS WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADDITIONAL INFO 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 24 MONTHS DID INDICATE ONE SIMILAR REPORT FOR THIS SYSTEM. SINCE NO SAMPLE HAS BEEN RETURNED FOR EVAL THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY. HOWEVER, THE MOST LIKELY CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A NONCONFORMING XENON LAMP. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING SURGERY, A SYSTEM MESSAGE DISPLAYED AND THE LAMP WAS OVERLY WARM. THE SYSTEM WAS SWITCHED OUT TO COMPLETE THE CASE. THERE WAS NO HARM TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK