BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1341640 · Received March 3, 2009

    Report

    Report Number
    1341640
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Date of Event
    February 3, 2008
    Report Date
    March 3, 2009
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    HQE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    THE TRANS PAR PLANA VIRECTOMY PROCEDURE WAS STARTED. AFTER THE START OF THE CASE, THE FOOT PEDAL WOULD NOT ACTIVATE. TROUBLE SHOOTING GUIDELINES FOR THE FOOT PEDAL WERE FOLLOWED WITH NO SUCCESS. THE SURGEON CANCELLED THE PROCEDURE AND THE EYE WAS CLOSED. A FOOT PEDAL WAS THEN BORROWED FROM ANOTHER INSTITUTION AND THE PROCEDURE WAS COMPLETED LATER IN THE DAY. PATIENT WAS STABLE AFTER THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * FOOT PEDAL HQE ALCON LABORATORIES, INC. 5065740997 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR