BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROM

    MDR report key: 2062411 · Received April 6, 2011

    Report

    Report Number
    3002985827-2011-00002
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 24, 2011
    Manufacturer
    MICROM INTL. GMBH
    Product Code
    IDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, A TECHNICIAN WAS ROUTINELY CUTTING BLOCKS. THE TECH WAS REMOVING THE BLOCK FROM THE CHUCK HOLDER. THE RED EMERGENCY BUTTON WAS ENGAGED ON THE INSTRUMENT. THIS DID NOT LOCK THE HANDWHEEL BECAUSE THE EMERGENCY STOP IS ONLY DESIGNED TO HALT OPERATION DURING AUTOMATIC (POWERED) MODE AND IS NOT INTENDED TO LOCK THE WHEEL DURING MANUAL (UNPOWERED) MODE. THIS RESULTED IN AN INJURY TO THE TECH IN THE FORM OF A LACERATION TO THE FINGER. THE TECH WAS TREATED AND INTERVENTION WAS REQUIRED IN THE FORM OF STITCHES. COMPANY WAS NOTIFIED ON (B)(6) 2011. TWO SAFETY FEATURES ARE EXPLAINED IN THE INSTRUCTIONS FOR USE TO PREVENT THIS TYPE OF INJURY FROM OCCURRING. THESE FEATURES INCLUDE A MANUAL BRAKE WHICH PREVENTS THE HANDWHEEL AND CHUCK FROM MOVING AND A SAFETY BRACKET THAT IS TO BE PLACED OVER THE KNIFE DURING BLOCK CHANGES. NEITHER SAFETY GUARD WAS EMPLOYED BY THE USER IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROM MICROTOME IDL MICROM INTL. GMBH HM355S-3

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention