BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA DM 2000

    MDR report key: 1302226 · Received January 30, 2009

    Report

    Report Number
    3003893952-2009-00001
    Event Type
    Injury
    Date Received
    January 30, 2009
    Date of Event
    December 30, 2008
    Report Date
    December 31, 2008
    Manufacturer
    LEICA MICROSYSTEMS CMS GMBH
    Product Code
    IBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INTERVIEWS CONDUCTED WITH THE CUSTOMER DURING THE INVESTIGATION, IT WAS COMMUNICATED THAT THE HOSPITAL'S BIOMEDICAL ENGINEERS HAD TESTED THE LEAKAGE FROM THE INSTRUMENTATION AND IT MEETS THE CSA ELECTRICAL STANDARDS. THEY SAID THE LEAKAGE WAS NOT ENOUGH TO CAUSE A SHOCK. ADDITIONALLY, THE SAFETY DOCUMENTATION IN THE OPERATING MANUAL STATUS THAT ANY INTERRUPTION OF THE GROUND WIRE INSIDE OR OUTSIDE OF THE DEVICE, OR RELEASE OF THE GROUND WIRE CONNECTION CAN CAUSE THE DEVICE TO BECOME HAZARDOUS. THE STAND WAS NOT PLUGGED IN AT THE TIME OF THE SHOCK AND, THEREFORE, IT WAS NOT GROUNDED. THE BIOMEDICAL ENGINEERS HAVE NOW CONNECTED AN ISOLATION TRANSFORMER INTO THE ELECTRICAL WALL OUTLET TO PLUG THE MICROSCOPE POWER CABLE INTO IT. BECAUSE LEICA TECHNICAL SERVICE PERSONNEL AND THEIR BIOMEDICAL ENGINEERS COULD NOT FIND A REASON WHY THE LAB TECHNICIAN RECEIVED A SHOCK, THE MICROSCOPE AND SYSTEM ARE BEING SENT FROM THE CUSTOMER TO ANOTHER COUNTRY'S MFR TO CONDUCT FURTHER TESTING. THEY HAVE BEEN PROVIDED A REPLACEMENT IN THE INTERIM. THEIR EQUIPMENT WILL BE RETURNED TO SERVICE AT THE HOSPITAL FOLLOWING THE MANUFACTURER'S INVESTIGATION. COMPARABLE SYSTEM EVALUATED AT FACTORY: NO PRODUCT FAILURES DETECTED.

    Description of Event or Problem · 1

    TECHNICIAN TOUCHED FOCUS KNOB WITH ONE HAND WHILE HER OTHER HAND WAS ON THE CONDENSER AND ALLEGEDLY RECEIVED A SHOCK. THE TECHNICIAN REPORTEDLY FELT BURNING AND NUMBNESS IN HER HAND AND WAS GOING TO SEE A NEUROLOGIST. IT IS UNKNOWN IF THE TECHNICIAN VISITED A NEUROLOGIST AND ANY MEDICAL INTERVENTION WAS REQUIRED. THE MICROSCOPE WAS PLUGGED INTO A LEICA LIGHT SOURCE. INVESTIGATION SHOWED THAT THE MICROSCOPE ORIGINALLY WAS NOT CONNECTED TO THE MAINS SUPPLY AS IT IS USED ONLY FOR REFLECTED LIGHT FLUORESCENCE WITH EXTERNAL LIGHT SOURCE. IT WAS DECIDED TO PLUG IT IN FOR PROPER GROUNDING. BIOMEDICAL DEPARTMENT PERSONNEL ONSITE TESTED THE UNIT AND CONCLUDED A LEAKAGE CURRENT AT .75MA WHICH IS WITHIN LIMITS OF ACCEPTANCE. EVENT DESCRIPTION INDICATES THAT THE DEVICE DID NOT CONTRIBUTE TO SERIOUS INJURY OR DEATH AND FURTHER INVESTIGATION WILL BE CONDUCTED IN RESPECT TO POTENTIAL BUILD UP OF STATIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEICA DM 2000 FLOURESCENCE MICROSCOPE IBK LEICA MICROSYSTEMS CMS GMBH DM 2000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other