BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA RM2255

    MDR report key: 2329876 · Received November 2, 2011

    Report

    Report Number
    8010478-2011-00010
    Event Type
    Injury
    Date Received
    November 2, 2011
    Date of Event
    September 30, 2011
    Report Date
    October 7, 2011
    Manufacturer
    LEICA BIOSYSTEMS GMBH
    Product Code
    IDL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THE FOLLOWING: SINCE THE HAND WHEEL WAS NOT LOCKED AND NO KNIFE GUARD WAS MOUNTED WHEN REMOVING THE SPECIMEN BLOCK, THE KNIFE HOLDER SLIPPED DOWN, WHEN ACTIVATED THE FOOT PEDAL, AND THUS INJURED THE FINGER AS A RESULT OF A USER ERROR. IN THE INSTRUCTION FOR USE IS WRITTEN THAT THE HANDWHEEL HAS TO BE LOCKED AND USER SHALL COVER THE KNIFE EDGE WITH THE KNIFE GUARD, WHEN REMOVING THE SPECIMEN BLOCK.

    Description of Event or Problem · 1

    CUSTOMER SUSTAINED AN INJURY TO HIS FINGER WHILE USING THE MICROTOME. HE WAS CUT BY THE MICROTOME BLADE. THE CUSTOMER WENT TO THE EMERGENCY ROOM AT HOSPITAL AND REQUIRED STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA RM2255 MICROTOME IDL LEICA BIOSYSTEMS GMBH RM2255

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention