BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA RM2235

    MDR report key: 5212156 · Received November 9, 2015

    Report

    Report Number
    8010478-2015-00007
    Event Type
    Injury
    Date Received
    November 9, 2015
    Date of Event
    October 12, 2015
    Report Date
    October 13, 2015
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IDO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE INCIDENT IS CURRENTLY ONGOING AND A FOLLOW UP INCLUDING THE OUTCOME OF THE INVESTIGATION WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THE FOLLOWING: THE INCIDENT WAS USER RELATED. DURING THE USAGE OF THE MICROTOME THE USER GRABBED TO A TOOL WHICH WAS STORED NEXT TO THE MICROTOME DEVICE. WHILST THIS ACTION THE USERS JACKET CAME TO THE KNIFE PROTECTOR OF THE DEVICE AND PUSHED THE BLADE GUARD DOWNWARDS. WHILE RETURNING BACK TO THE WORK POSITION THE USER GRASPED INTO THE BLADE OF THE KNIFO HOLDER WITH HIS LEFT HAND, CAUSING LACERATIONS OF THE INDEX AND MIDDLE FINGERS.

    Description of Event or Problem · 1

    ON (B)(6) 2015, LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT A CUSTOMER GOT AN INJURY TO HIS INDEX FINGER AND MIDDLE FINGER DURING THE USAGE OF THE MICROTOME. MEDICAL TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741852 LEICA RM2235 MICROTOME IDO LEICA BIOSYSTEMS NUSSLOCH GMBH 1492235EUUL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other