BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 814672 · Received January 23, 2007

    Report

    Report Number
    814672
    Event Type
    Malfunction
    Date Received
    January 23, 2007
    Date of Event
    January 18, 2007
    Report Date
    January 23, 2007
    Manufacturer
    CARL ZEISS, INC
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    FOOT PEDAL ON EYE MICROSCOPE FOUND TO BE MALFUNCTIONING. PATIENT WAS IN THE ROOM ALREADY PREPPED AND DRAPED. DOCTOR DISCOVERED THE PROBLEM. PATIENT WAS RETURNED TO THE HOLDING ROOM, MONITORED AND THEN RETURNED TO AM SURGERY. ALL OTHER CASES FOR THIS DOCTOR WERE CANCELLED. BIOMED CALLED AND THEY ARE WORKING ON THE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MICROSCOPE, SURGICAL EPT CARL ZEISS, INC ZMS124 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *