BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STORZ

    MDR report key: 719666 · Received February 27, 2006

    Report

    Report Number
    719666
    Event Type
    Malfunction
    Date Received
    February 27, 2006
    Date of Event
    January 18, 2006
    Report Date
    February 27, 2006
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    FSW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE LIGHTS WENT OUT ON THE ENT MICROSCOPE WHILE DOCTOR WAS DOING AN EAR PROCEDURE. BIOMEDICAL ENGINEERING WAS CALLED AND ANOTHER ENT MICROSCOPE WAS SUBSTITUTED. BIOMED HAS ARCHIVED THE LIGHT SOURCE BECAUSE WE CAN NOT PURCHASE THE FAILED PART FROM THE MANUFACTURER, OR A THIRD PARTY. THE LIGHT SOURCE WAS REPLACED WITH ANOTHER OLDER LIGHT SOURCE. IT SEEMS TO BE AN ACCEPTABLE TEMPORARY SOLUTION UNTIL THE ENTIRE MICROSCOPE AND LIGHT SOURCE ARE REPLACED WITH NEWER TECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ ENT MICROSCOPE, LIGHT FSW KARL STORZ ENDOSCOPY-AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR