BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA RM2255

    MDR report key: 5093857 · Received September 22, 2015

    Report

    Report Number
    8010478-2015-00006
    Event Type
    Injury
    Date Received
    September 22, 2015
    Date of Event
    July 7, 2015
    Report Date
    August 24, 2015
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IDO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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

    THIS INCIDENT WAS PRESUMABLY USER RELATED. WHILE THE USERS FINGERTIP WAS IN THE CUTTING AREA, SHE ACTIVATED THE CUTTING PROCESS BY 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 SEND OUT WITH RECOMMENDATION IN FUTURE TO FOLLOW THE DESCRIPTION PROVIDED IN THE INSTRUCTION FOR USE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE CUSTOMER REPORTED AN INJURY USING A ROTARY MICROTOME. THE USER WAS TREATED FOR HER INJURY AT (B)(6) AND THEY WERE ABLE TO REATTACH THE END OF HER FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624318 LEICA RM2255 MICROTOM IDO LEICA BIOSYSTEMS NUSSLOCH GMBH 1492255UL01

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other