BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA RM 2155 AUTOMATED MICROTOME

    MDR report key: 325569 · Received April 5, 2001

    Report

    Report Number
    1423337-2001-00001
    Event Type
    Injury
    Date Received
    April 5, 2001
    Date of Event
    November 8, 2000
    Report Date
    March 7, 2001
    Manufacturer
    LEICA MICROSYSTEMS, INC.
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE REMOVING A SPECIMEN FROM THE MICROTOME MODEL RM 2155, THE USER REPORTEDLY PRESSED THE FOOT PEDAL BY ACCIDENT, ACTIVATING THE MOTORIZED SPECIMEN CUTTING KNIFE WHICH THEN CAME IN CONTACT WITH THE USER'S HAND, CUTTING THE THUMB AND SEVERING THE LEFT INDEX FINGER TO THE FIRST KNUCKLE. THE USER REPORTEDLY RECEIVED TREATMENT AT A HOSP EMERGENCY ROOM TO CLOSE THE WOUNDS. THE EMERGENCY ROOM PHYSICIAN TRIED TO REATTACH THE SEVERED PORTION OF THE INDEX FINGER BUT WAS UNABLE TO DO SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14993 LEICA RM 2155 AUTOMATED MICROTOME TISSUE PROCESSING EQUIPMENT IEO LEICA MICROSYSTEMS, INC. RM2155 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| S