BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 3912855 · Received May 14, 2014

    Report

    Report Number
    2028159-2014-00897
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITION REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THAT DURING A VITRECTOMY PROCEDURE, THE FOOT PEDAL TREADLE WOULD NOT WORK AND THE PROBE WOULD NOT CUT NOR ASPIRATE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SYSTEM AND NEW PAK. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER STATING ULTIMATELY THE PROBLEM WAS WITH THE FOOTSWITCH CORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288275 CONSTELLATION VISION SYSTEM UNIT, PHARCOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CONSTELLATION FOOTSWITCH