BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROM

    MDR report key: 2058926 · Received April 1, 2011

    Report

    Report Number
    3002985827-2011-00001
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 3, 2011
    Manufacturer
    MICROM INTERNATIONAL GMBH
    Product Code
    IDL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, A TECHNICIAN WAS ROUTINELY CUTTING BLOCKS. THE TECH PRESSED THE STOP BUTTON ON THE CONSOLE AND THE CHUCK CAME TO THE TOP AND PAUSED. AS IT PAUSED, THE TECH GRASPED THE BLOCK TO REMOVE IT FROM THE CHUCK AND THE CHUCK THEN ALLEGEDLY BEGAN TO MOVE. THIS RESULTED IN INJURY TO THE TECH IN THE FORM OF A LACERATION TO THE INDEX FINGER AND THUMB. THE TECH WAS TREATED AND INTERVENTION WAS REQUIRED TO PREVENT PERMANENT DAMAGE. COMPANY WAS NOTIFIED ON (B)(6) 2011. TWO SAFETY FEATURES EXIST TO PREVENT THIS TYPE OF INJURY AS DETAILED IN THE INSTRUCTIONS FOR USE. THESE FEATURES INCLUDE A MANUAL BRAKE WHICH PREVENTS THE WHEEL AND CHUCK FROM MOVING AND A PHYSICAL GUARD THAT IS PLACED OVER THE KNIFE DURING BLOCK CHANGES. NEITHER SAFETY FEATURE WAS EMPLOYED BY THE USER IN THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention