BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA MICROSYSTEMS

    MDR report key: 696060 · Received April 4, 2006

    Report

    Report Number
    MW1038412
    Event Type
    Injury
    Date Received
    April 4, 2006
    Report Date
    April 4, 2006
    Manufacturer
    LEICA MICROSYSTEMS
    Product Code
    EPT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PEDIATRIC PT RECEIVED 3RD DEGREE BURNS DURING A BRACHIAL PLEXIS SURGICAL CASE FROM DIRECT LIGHT INTENSITY OF A SURGICAL MICROSCOPE IN JANUARY 2006 WITH A FOLLOW ON COMPLAINT BY THE FAMILY IN FEBRUARY 2006. THE MICROSCOPE SETTING WAS USED AT LIGHT INTENSITY OF 6 AT A WORKING DISTANCE OF 30CM FOR APPROX 2 HOURS. THE MICROSCOPE WAS APPROX 3 MONTHS OLD AND NO SPECIFIC THERMO SAFE ZONES WERE IDENTIFIED IN THE OPERATOR'S/SERVICE MANUAL OR DURING THE OPERATORS ONSITE TRAINING. THE SAFE ZONES ARE VARIABLE ACCORDING TO LIGHT INTENSITY. AN ADDENDUM WAS PROVIDED TO PROPERLY ILLUSTRATE THE SAFE WORKING ZONES AND DISTANCE AFTER THE INCIDENT OCCURRED. THE COMPANY WAS CONTACTED AND THE REP COMPLIED AND PLACED WARNING LABELS ON THE UNIT WITHIN 48 HOURS OF THE REPORTED INCIDENT. THE CO ALSO SENT AN ADDENDUM ILLUSTRATING DISCUSSION OF XE LIGHT IN USE WITH NEUROSURGICAL MICROSCOPES. THE INSTRUMENT WAS ALSO EXAMINED BY LEICA AND FOUND TO BE WITHIN FACTORY SPECIFICATIONS. THE UNIT WAS FOUND TO BE SAFE IF USED ACCORDING TO RECOMMENDATIONS IN THE USER MANUAL. THE CO EMPHASIZED THAT THE MAXIMUM LIGHT INTENSITY SHOULD ONLY BE USED WHEN THE MAXIMUM WORKING DISTANCE RANGE IS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA MICROSYSTEMS SURGICAL MICROSCOPE EPT LEICA MICROSYSTEMS M520-0H3 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization