BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA RM2255

    MDR report key: 5099168 · Received September 23, 2015

    Report

    Report Number
    1423337-2015-00018
    Event Type
    Injury
    Date Received
    September 23, 2015
    Date of Event
    July 7, 2015
    Report Date
    August 24, 2015
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IDO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015 WHILE ON-SITE SERVICING ANOTHER INSTRUMENT, A LEICA BIOSYSTEMS FIELD SERVICE ENGINEER (FSE) WAS NOTIFIED BY A USER THAT EARLIER IN THE SUMMER, SHE CUT THE END OF HER FINGER OFF WHILE USING THE LEICA RM2255. PER THE USER, THE INJURY OCCURRED ON (B)(6) 2015. THE USER WAS TREATED FOR HER INJURY AT (B)(6) AND THEY WERE ABLE TO REATTACH THE END OF HER FINGER. THIS INCIDENT WAS NOT INITIALLY REPORTED TO LEICA BIOSYSTEMS BUT WAS REPORTED TO THE HOSPITAL, (B)(6).

    Description of Event or Problem · 1

    THE LEICA MANUFACTURER COMPLETED THEIR INVESTIGATION AND FOUND THAT THIS INCIDENT WAS PRESUMABLY USER RELATED. WHILE THE USERS FINGERTIP WAS IN THE CUTTING AREA, SHE ACTIVATED THE CUTTING PROCESS VIA THE FOOT PEDAL. SAFETY GLOVES WERE NOT WORN, AS DESCRIBED IN THE INSTRUCTION FOR USE: "WHEN WORKING WITH MICROTOMES, PERSONAL SAFETY PRECAUTIONS MUST ALWAYS BE TAKEN. IT IS MANDATORY TO WEAR WORK SAFETY SHOES, SAFETY GLOVES, A MASK AND SAFETY GOGGLES." A CUSTOMER FACING LETTER WILL BE SENT OUT WITH RECOMMENDATION IN FUTURE TO FOLLOW THE DESCRIPTION PROVIDED IN THE INSTRUCTION FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627986 LEICA RM2255 ROTARY MICROTOME, IDO LEICA BIOSYSTEMS NUSSLOCH GMBH 1492255UL01

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other