BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OH4

    MDR report key: 2130513 · Received June 9, 2011

    Report

    Report Number
    2130513
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    April 29, 2011
    Report Date
    June 9, 2011
    Manufacturer
    LEICA MICROSYSTEMS
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BRAKE ON THE MICROSCOPE RELEASED BY ITSELF DURING THE PROCEDURE (CRANIOTOMY). THE SURGEON HAD AN INSTRUMENT INSIDE THE BRAIN AT THE TIME. THE BRAKE LET GO SUDDENLY WITHOUT WARNING AND MADE A VERY LOUD NOISE. NO ONE WAS CLOSE TO THE BRAKE RELEASE WHEN THIS HAPPENED. EQUIPMENT CHECKED EARLIER TO ENSURE IT WAS FUNCTIONAL.====================== MANUFACTURER RESPONSE FOR MICROSCOPE, OH4 (PER SITE REPORTER)======================THE EQUIPMENT REPRESENTATIVE CAME AND REPAIRED THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OH4 MICROSCOPE EPT LEICA MICROSYSTEMS M5250H4 OH4-50110

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR