BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HISTOCORE BIOCUT

    MDR report key: 19444691 · Received June 2, 2024

    Report

    Report Number
    8010478-2024-00011
    Event Type
    Injury
    Date Received
    June 2, 2024
    Date of Event
    May 3, 2024
    Report Date
    June 2, 2024
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IDO
    UDI-DI
    04049188204813
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT WAS MANUFACTURED IN MAY 2022, AND OUR REVIEW OF THE ASSOCIATED DEVICE HISTORY RECORD WHICH INDICATED THE FUNCTIONS OF THIS INSTRUMENT AND BLADE HOLDER ARE OKAY, AND THERE¿S NO OTHER POTENTIAL ISSUES DURING THE MANUFACTURING PROCESS. THE USER INJURED HER LEFT ARM WHEN SHE WAS PICKING UP A BLOCK TO CUT IT, BECAUSE THE CUTTING EDGE OF SHARP BLADE IS NOT COVERED WITH THE RED SAFETY GUARD OF BLADE HOLDER. A CUSTOMER FACING LETTER WAS SENT OUT TO THE CUSTOMER WITH RECOMMENDATION, TO FOLLOW THE DETAILED DESCRIPTION IN HISTOCORE BIOCUT IFU 1V8L EN.

    Description of Event or Problem · 0

    WE ARE EXPERIENCING AN ISSUE WITH OUR BIOCUT SN (B)(6) ; THE BLADE HOLDER IS NOT ABLE TO LOCK CORRECTLY AND HAS BEEN REPORTED TO PRODUCE A NOISE WHEN CUTTING BLOCKS THIS HAS RESULTED IN AN ACCIDENT WITH ONE STAFF MEMBER. THE STAFF MEMBER WAS USING THE MICROTOME AND THE BLADE HOLDER WAS LOOSE AND AS CONSEQUENCE SHE CUT HER ARM. THE STAFF MEMBER WENT TO A&E AND REQUIRED STITCHES, GLUE, STEROSTRIP AND TETANUS SHOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629448 HISTOCORE BIOCUT MICROTOME, ROTARY IDO LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE BIOCUT, CONFIG. 1 04049188204813

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female