BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 2912129 · Received January 11, 2013

    Report

    Report Number
    2955842-2013-00154
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Report Date
    January 15, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) VISITED THE SITE TO VERIFY THAT THE CUSTOMER WAS USING THE CORRECT ELECTROSURGICAL UNIT (ESU), VALLEY LAB FORCE FX, WITH THE CORRECT ENERGY ACTIVATION CABLE (BLUE VALLEY LAB CABLE). THE FSE CONFIRMED THAT THE EQUIPMENT WAS COMPATIBLE. BASED ON THE INFORMATION PROVIDED TO THE FSE BY THE OPERATING ROOM SURGICAL STAFF, THIS SURGEON IS THE ONLY SURGEON WHO HAD EXPERIENCED THIS ISSUE. FURTHERMORE, IT WAS STATED THAT THE SURGEON DID NOT REALIZE SHE WAS PRESSING THE FOOT PEDAL, ACTIVATING ENERGY TO THE BIPOLAR INSTRUMENT. THE FSE EXPLAINED TO THE CUSTOMER THE IMPORTANCE OF CALLING ISI'S TECHNICAL SUPPORT IN SUCH INSTANCES. THE FSE ALSO PERFORMED A COMPLETE SYSTEM VERIFICATION AND ELECTRICAL SAFETY TEST DURING THE PREVENTIVE MAINTENANCE VISIT. TOGETHER WITH THE HOSPITAL'S BIOMED PERSONNEL, THE ENGINEER VERIFIED BOTH BIPOLAR AND MONO-POLAR FUNCTIONALITY WITH THE CUSTOMER'S INSTRUMENTS. THE FSE WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED FAILURE. THE FSE TESTED THE SYSTEM SETUP AND FOUND IT TO BE WORKING TO MANUFACTURER'S SPECIFICATIONS WITH NO DEFECT OR MALFUNCTION. ON (B)(4) 2013, ISI CONTACTED INITIAL REPORTER BIOMED, AT (B)(6). HE INDICATED THAT HE WAS NOT AWARE OF ANY PATIENT INJURIES RELATED TO THESE, INCIDENTS REPORTED.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, ISI RECEIVED A USER FACILITY MEDWATCH FORM FROM THE FDA (B)(4). ACCORDING TO THE INFORMATION REPORTED TO THE FDA BY THE PHYSICIAN, 'THE SURGEON WAS USING THE DAVINCI SYSTEM FOR A HYSTERECTOMY. THE PRECISE BIPOLAR INSTRUMENT WAS INSERTED AND WHEN SHE GRASPED TISSUE THE CURRENT ACTIVATED WITHOUT THE FOOT PEDAL BEING PRESSED. THE AUDIBLE POWER SOUND WAS HEARD AND THE GRASPED TISSUE WHICH FORTUNATELY WAS A FALLOPIAN TUBE WAS CAUTERIZED. THE ENTIRE CREW IN THE OPERATING ROOM WITNESSED THIS EVENT. SHE THEN GRASPED THE UTERUS IN SEVERAL LOCATIONS AND THE INSTRUMENT AGAIN TRANSMITTED ENERGY WITH THE GRASPING OF TISSUE WITHOUT USE OF THE FOOT PEDAL. THE DEVICE WAS REMOVED AND THE PK DEVICE INSERTED, TESTED AND THE CASE PROCEEDED WITHOUT INCIDENT. EXAM OF THE BOWEL AND SURROUNDING TISSUE DISCLOSED NO INJURY AND THE PATIENT WAS DISCHARGED THE NEXT MORNING. THIS ONLY OCCURRED 2 DAYS AGO HOWEVER, SO POTENTIAL FOR DELAYED INJURY STILL EXISTS. A SIMILAR EVENT HAD OCCURRED 2 MONTHS AGO USING A FENESTRATED BIPOLAR DEVICE ON THE SAME SYSTEM AND GENERATOR WHERE UPON INSERTION OF THE INSTRUMENT ENERGY WAS IMMEDIATELY DELIVERED PRIOR TO FOOT PEDAL ACTIVATION. THE DEVICE WAS DISCONNECTED, REINSERTED AND THE PROBLEM DID NOT RECUR ON THE SECOND ATTEMPT.' AS STATED ON THE INITIAL MDR, ISI CONTACTED INITIAL REPORTER BIOMED, AT THE MEMORIAL HEALTH SYSTEM HOSPITAL. HE INDICATED THAT HE WAS NOT AWARE OF ANY PATIENT INJURIES RELATED TO THE INCIDENTS REPORTED. SEVERAL ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION REGARDING THIS EVENT WITHOUT SUCCESS. AS OF THE DATE OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED FROM THE SITE. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS MDR WAS CREATED TO ADDRESS THE ONE OF THE TWO SEPARATE CASES REPORTED BY THE SURGEON ON MDR 2955842-2013-00120, 'BASED ON ADDITIONAL INFORMATION PROVIDED TO THE FIELD SERVICE ENGINEER, THE SURGEON CLAIMED THAT THE BIPOLAR INSTRUMENT HAD FIRED ON ITS OWN IN TWO SEPARATE CASES. THE SURGEON DID NOT REPORT THESE INCIDENTS TO INTUITIVE SURGICAL AT THE TIME OF THE OCCURRENCES.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17862 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P7

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES