BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3031077 · Received March 28, 2013

    Report

    Report Number
    2028159-2013-00542
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    January 1, 2012
    Report Date
    March 4, 2013
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K082845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND WAS UNABLE TO CONFIRM THE REPORTED EVENT. THE SYSTEM WAS TESTED WITH A CAUTERY LOAD BOX AND FOUND TO BE WITHIN SPECIFICATIONS. UNRELATED TO THE REPORTED EVENT, SYSTEM SOFTWARE WAS UPGRADED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. 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 THE SYSTEM'S EVENT LOG DID NOT REVEAL ANY SYSTEM MESSAGES RELATED TO CAUTERY POWER. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE COULD NOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING A PROCEDURE, THE SYSTEM'S CAUTERY WAS NOT WORKING. AN ALTERNATE CABLE WAS USED, BUT THE ISSUE REMAINED. THE CASE WAS COMPLETED USING A DIFFERENT CAUTERY SYSTEM. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129686 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1