BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 1832065 · Received September 3, 2010

    Report

    Report Number
    2028159-2010-01640
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    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
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOOTSWITCH WAS RECEIVED AND INSPECTED. THE LEFT AND RIGHT WING COVERS AND REAR BUMPER WERE DAMAGED. THE HEEL REST AND BASE PLATE WERE WORN. THE HOUSING AND HEEL BASE WERE BROKEN. THE FOOTSWITCH WAS REPAIRED. THE FOOTSWITCH WAS CLEANED AND LUBRICATED. THE FOOTSWITCH WAS THEN TESTED AND MET ALL PRODUCT SPECS. THE ROOT CAUSE OF THE REPORTED PROBLEM IS UNK. THE ISSUE WAS UNABLE TO BE REPLICATED IN-HOUSE. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THE SYSTEM OR THE FOOTSWITCH. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "FOOTSWITCH NOT RESPONDING" (NO CODE AVAILABLE). THE NURSE REPORTED THE FOOTSWITCH STOPPED RESPONDING. THE INCISION HAD BEEN MADE, BUT SURGERY HAD NOT STARTED. THE FOOTSWITCH WAS SWITCHED OUT WITHOUT RESOLUTION. THE SYSTEM WAS THEN SWITCHED OUT AND THE CASE WAS COMPLETED. THERE WAS A 20 MINUTE DELAY. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK