BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESEARCH CRYOSTAT LEICA CM3050 S

    MDR report key: 1652714 · Received April 5, 2010

    Report

    Report Number
    8010478-2010-00001
    Event Type
    Injury
    Date Received
    April 5, 2010
    Date of Event
    February 22, 2010
    Report Date
    March 4, 2010
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IDP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION FROM INVESTIGATION: NO CORRECTIVE ACTION IS REQUIRED. CAUSE OF PROBLEM WAS DUE TO USER ERROR - USER NOT FOLLOWING INSTRUCTIONS IN USER MANUAL. REFERENCE PAGE 9 AND 10 OF CURRENT OPERATORS MANUAL REQUIRING THAT THE HANDWHEEL ALWAYS BE "LOCKED" IN A SAFE POSITION BEFORE PLACING HANDS IN CRYOSTAT.

    Description of Event or Problem · 1

    ON MARCH 4, 2010, LEICA MICROSYSTEMS RECEIVED A COMPLAINT THAT WHILE USING A CM3050 CRYOSTAT, A LAB TECHNICIAN EXPERIENCED A CUT ON HER FINGER THAT REQUIRED STITCHES. THE CUTTING BLADE ON THIS MODEL OF CRYOSTAT CAN BE ACTUATED BY HAND OR BY USING A FOOTSWITCH. THE TECHNICIAN WAS NOT USING THE FOOTSWITCH AT THE TIME AND THE FOOTSWITCH WAS OFF TO THE SIDE OF THE CRYOSTAT. ANOTHER TECH APPROACHED HER, LOOKING OVER HER SHOULDER TO SEE WHAT SHE WAS DOING. THE SECOND TECHNICIAN INADVERTENTLY STEPPED ON THE FOOT SWITCH, ACTUATING THE BLADE WHILE THE USER'S HAND WAS IN THE CRYOSTAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESEARCH CRYOSTAT LEICA CM3050 S CRYOSTAT IDP LEICA BIOSYSTEMS NUSSLOCH GMBH CM3050S NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other