BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA RM2155

    MDR report key: 2259092 · Received September 15, 2011

    Report

    Report Number
    8010478-2011-00008
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 25, 2011
    Manufacturer
    LEICA BIOSYSTEMS GMBH
    Product Code
    IDL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THE FOLLOWING: THE MICROTOMES SAFETY GUARD WAS BROKEN THE DAY BEFORE, SO PRESUMABLY THE LAB TEMPORARY EMPLOYEE COULD NOT IDENTIFY THE DEFECTIVE KNIFE HOLDER, AND HAD BEEN CUT ON THE RIGHT INDEX FINGER. THE KNIFE HOLDER WITH THE KNIFE GUARD WAS COMPLETE REPLACED, AND A PERFORMANCE TEST WAS CONDUCTED TO ENSURE THAT THE DEVICE WAS WORKING PROPERLY.

    Description of Event or Problem · 1

    CUSTOMER SUSTAINED AN INJURY TO HIS RIGHT INDEX FINGER TIP WHILE USING THE MICROTOME. HE WAS CUT BY THE MICROTOME BLADE. THE CUSTOMER WENT TO THE EMERGENCY ROOM AT HOSPITAL. STITCHES WERE NOT REQUIRED, ONLY A BANDAGE WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA RM2155 MICROTOME IDL LEICA BIOSYSTEMS GMBH RM2155

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention