BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITI VISION SYSTEM OZIL

    MDR report key: 3111843 · Received May 7, 2013

    Report

    Report Number
    2028159-2013-00876
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 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
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CALLED TO REPORT A CUT IN THE FOOTSWITCH CABLE AND REQUESTED A REPLACEMENT. THE CUSTOMER ORDERED A FOOTSWITCH CABLE. THE FACILITY DID NOT REQUEST SERVICE. THERE WAS NO SAMPLE RETURNED FOR EVALUATION 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 DID INDICATE 1 RELATED REPORT FOR THIS SYSTEM. THE ROOT CAUSE OF THE REPORTED EVENT WAS ATTRIBUTED TO A NONCONFORMING FOOTSWITCH CABLE DUE TO A CUT. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE SYSTEM DISPLAYED A FOOTSWITCH FAILURE MESSAGE AND A CUT IN THE FOOTSWITCH CABLE. THE SYSTEM WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED. THERE WAS A DELAY GRATER THAN 15 MINUTES. THERE WAS NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200098 INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER INFINITI OZIL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK