BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1971475 · Received January 27, 2011

    Report

    Report Number
    2955842-2011-00030
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 3, 2010
    Report Date
    January 6, 2011
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K063220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON SITE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER (FSE) WAS UNABLE TO REPLICATE THE CUSTOMER REPORTED MONOPOLAR AND BIPOLAR CAUTERY ACTIVATION ISSUES. INSPECTION FOUND THE BRACKET ON THE BACK OF THE MONOPOLAR CONNECTION TO BE BROKEN, RESULTING IN A LOOSE CONNECTION TO THE ELECTRICAL SURGICAL UNIT (ESU) AND THAT THE CAUTERY CABLES FROM THE ESU TO THE MONOPOLAR AND BIPOLAR INSTRUMENTS WERE INTERTWINED DURING THE PROCEDURE. ENGINEERING REVIEW INDICATES THAT THESE CONDITIONS ARE UNLIKELY TO HAVE LED TO THE CAUTERY ACTIVATION ISSUE REPORTED BY THE SURGEON. THE MONOPOLAR INSTRUMENT DRIVES CURRENT INTO THE PATIENT BODY WHICH RETURNS TO THE ELECTRICAL GROUND THROUGH THE PATH OF LEAST RESISTANCE, USUALLY THE GROUNDING PAD CONNECTED TO THE PATIENT. IT IS POSSIBLE FOR THE BI-POLAR INSTRUMENT TO BE THE PATH OF LEAST RESISTANCE, DUE TO CLOSE TIP PROXIMITY OR INSUFFICIENT CONTACT WITH THE GROUNDING PAD, CAUSING CURRENT TO FLOW THROUGH THE BIPOLAR TIPS AND MAKE THEM APPEAR TO BE ACTIVATED. IT IS THE VIEW OF ISI ENGINEERING THAT THIS IS THE MOST LIKELY CAUSE OF THE REPORTED ISSUE. THIS IS AN ISSUE INHERENT IN THE USE OF ENERGY INSTRUMENTS AND NOT A FLAW IN THE DA VINCI SURGICAL SYSTEM. THE SURGEON REFERRED TO THE WIRES BETWEEN THE ESU AND THE INSTRUMENTS AS HAVING BEEN BUNDLED. SINCE THESE ARE NON-SHIELDED CABLES CARRYING HIGH CURRENT, IT IS CONCEIVABLE THAT CURRENT IN ONE CABLE COULD HAVE INDUCED CURRENT IN THE OTHER. SINCE THIS IS PART OF THE ESU SETUP, IT IS OUTSIDE OF INTUITIVE'S EXPERTISE AND WOULD BE BEST ADDRESSED BY THE ESU MANUFACTURER. FOR PRECAUTIONARY PURPOSES, THE FSE REPLACED THE SSC FOOTREST CAUTERY CABLE. THE FOOTREST CAUTERY CABLE CONNECTS THE SSC FOOTSWITCH PANEL TO THE ESU UNIT, CAUSING CAUTERIZATION TO OCCUR WHEN THE SURGEON ACTIVATES THE APPLICABLE MONO OR BIPOLAR FOOT PEDAL. AS OF (B)(6) 2011, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    ON (B)(4) 2011, MEDWATCH UF / IMPORTER REPORT (B)(4) WAS RECEIVED. IT WAS REPORTED BY THE HOSPITAL THAT DURING A DA VINCI S RADICAL VAGINECTOMY PROCEDURE, WHEN THE SURGEON ACTIVATED THE MONOPOLAR CAUTERY FOOT PEDAL, THE BIPOLAR INSTRUMENT BECAME ACTIVATED AS WELL AS THE MONOPOLAR INSTRUMENT. IT WAS NOTED BY THE SURGICAL STAFF THAT THE MONOPOLAR AND BIPOLAR CAUTERY CABLES FROM THE ELECTRICAL SURGICAL UNIT (ESU) TO THE DA VINCI INSTRUMENTS WERE INTERTWINED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SYSTEM, INSTRUMENTS, ACCESSORIES, & ES