BEUDAMED
    FDA Adverse Event Other Summary report: N

    FREEDOM EVO-2 200

    MDR report key: 3232296 · Received July 15, 2013

    Report

    Report Number
    3003402518-2013-00004
    Event Type
    Other
    Date Received
    July 15, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 15, 2013
    Manufacturer
    TECAN SCHWEIZ AG
    Product Code
    JQW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A TECAN FIELD SERVICE ENGINEER WENT TO THE LABORATORY TO EVALUATE THE INSTRUMENT. THE DOOR LOCKS WERE DISABLED ALLOWING FOR EMPLOYEES TO REACH INTO THE INSTRUMENT WHILE IN OPERATION. TECAN INSTALLS INSTRUMENTATION WITH DOOR LOCKS ENABLED. ADDITIONALLY, TECAN OPERATOR'S MANUALS AND WARNING LABELS ON INSTRUMENT CAUTION OPERATORS TO NOT REACH INTO A RUNNING INSTRUMENT AS INJURY IS POSSIBLE. AFTER INVESTIGATION, IT IS UNCLEAR WHEN OR WHO DISABLED THE DOOR LOCKS. THE TECAN SERVICE ENGINEER ENABLED THE DOOR LOCKS. THE TECAN SERVICE ENGINEER ENABLED DOOR LOCKS AND INSTRUMENT PASSED APPLICABLE DIAGNOSTIC TESTING. NO EVIDENCE OF MALFUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    AN EVO INSTRUMENT OPERATOR REACHED WITH THEIR HAND INTO THE INSTRUMENT WHILE IN OPERATION AND THE PICK AND PLACE ARM (PNP GRIPPER) HIT THEIR HAND PINNING IT TO THE INSIDE OF THE SAFETY SHIELD RESULTING IN A BRUISE. ON THE DAY OF THE EVENT, THE OPERATOR'S HAND WAS SWOLLEN AND HURTING. THERE WERE NO CUTS OR BROKEN SKIN AND THE OPERATOR DID NOT SEEK FIRST AID OR MEDICAL TREATMENT. THE OPERATOR WAS A CONTRACT EMPLOYEE OF THE LABORATORY AND INFORMED LABORATORY STAFF 3 DAYS LATER OF THE EVENT. THE LABORATORY REPORTED TO TECAN THE EVENT ON (B)(6). AT THAT TIME, THE OPERATOR INDICATED THE SWELLING HAD EXTENDED TO THE ARM. LAB STAFF ADVISED OPERATOR TO CONSULT A PHYSICIAN. NO FURTHER INFORMATION HAS BECOME AVAILABLE ABOUT THE NATURE OR EXTENT OF THE INJURIES OR TREATMENT REQUIRED. TECAN MADE MULTIPLE ATTEMPTS TO OBTAIN THIS INFORMATION. THE OPERATOR'S INJURY WAS THE RESULT OF DISABLED DOOR LOCKS WHICH ALLOWED THE OPERATOR TO REACH INSIDE A RUNNING INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327664 FREEDOM EVO-2 200 PIPETTING STATION FOR CLINICAL USE JQW TECAN SCHWEIZ AG EVO-2 200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other