BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3102161 · Received May 3, 2013

    Report

    Report Number
    2028159-2013-00838
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND REPLACED THE FOOTSWITCH INTERFACE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AND THE FOOTSWITCH CABLE. PREVENTIVE MAINTENANCE (PM) WAS PERFORMED. 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 INDICATE ANY RELATED SYSTEM MESSAGES. A REVIEW OF COMPLAINTS FOR THE LAST (B)(4) DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A PATIENT HAD RECEIVED PERIBULBAR ANESTHESIA IN PREPARATION FOR SURGERY. THE PROCEDURE HAD NOT YET STARTED WHEN THE FOOTSWITCH PRESENTED WITH ISSUES. THE CASE WAS CANCELED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195045 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INFINITI ENHANCED FOOTSWITCH| INFINITI FOOTSWITCH CABLE