BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3995680 · Received August 8, 2014

    Report

    Report Number
    2955842-2014-04826
    Event Type
    Other
    Date Received
    August 8, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE FIELD INVESTIGATION PERFORMED, THE FSE WAS UNABLE TO REPLICATE THE ISSUES EXPERIENCED BY THE SITE. HOWEVER, ADDITIONAL REVIEW OF THE SITE'S SYSTEM LOGS BY ISI ENGINEERING FOUND THAT A NUMBER OF RECURING 816 BATTERY CAPACITY FAULTS OCCURED DURING THE SURGICAL PROCEDURE. IT WAS CONCLUDED THAT THE SYSTEM ERROR CODE 816 LIKELY OCCURRED BECAUSE THE SYSTEM BATTERIES WERE DEPLETED DUE TO THE SYSTEM RUNNING ON BATTERY FOR AN EXTENDED PERIOD OF TIME AFTER A LOSS OF AC POWER. SYSTEM ERROR CODE 23024 IS AN INFORMATIONAL LOG AND IS NOT A USER FACING SYSTEM ERROR CODE. THE OCCURRENCE OF SYSTEM ERROR CODE 23024 CONFIRMS THE ECM CANNULA MOUNT ISSUE EXPERIENCED BY THE SITE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: A DA VINCI PYELOPLASTY PROCEDURE WAS CONVERTED TO OPEN SURGICAL TECHNIQUES AFTER THE SITE EXPERIENCED ISSUES WITH THE DA VINCI SURGICAL SYSTEM. AS OF (B)(6) 2014, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL. THIS REPORT DOES NOT ADMIT THAT THE REPORT OR INFORMATION SUBMITTED UNDER THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, INTUITIVE SURGICAL OR INTUITIVE SURGICAL EMPLOYEES, CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PYELOPLASTY PROCEDURE, THE BATTERY INDICATOR WAS DISPLAYED ON THE MONITOR. THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) FOR TECHNICAL SUPPORT. WITH THE ASSISTANCE OF THE TECHNICAL SUPPORT ENGINEER (TSE), THE SITE PERFORMED AN EMERGENCY POWER OFF (EPO) OF THE PATIENT SIDE CART (PSC) AND SWAPPED TO A DIFFERENT POWER OUTLET. THE ISSUE WAS RESOLVED AS THE CUSTOMER INDICATED THAT THE PSC WAS RUNNING ON AC POWER AND THE PSC BATTERY INDICATOR WAS ILLUMINATED GREEN. AFTER HOMING THE SYSTEM, THE SITE DISCOVERED THAT THE CANNULA MOUNT FOR THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) ARM HAD A BROKEN SCREW, PREVENTING ENGAGEMENT OF THE CANNULA ONTO THE CANNULA MOUNT. THE SITE INDICATED THAT THEY HAD A REPLACEMENT CANNULA MOUNT; HOWEVER, THE SURGICAL STAFF INDICATED THAT THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED PROCEDURE TO OPEN SURGICAL TECHNIQUES. THE ECM IS THE CAMERA ARM LOCATED ON THE PATIENT SIDE CART WHICH PROVIDES THE STERILE INTERFACE FOR THE 3D ENDOSCOPE. IN ADDITION, JUST AS THE SITE WAS ENDING THE CALL, THE TSE WAS ADVISED THAT THEY HAD ALSO EXPERIENCED ISSUES WITH THE MONOPOLAR/BIPOLAR ENERGY. THE TSE WAS TOLD BY THE SITE THAT THEY WERE USING A VALLEY LAB ELECTROSURGICAL UNIT. NO OTHER INFORMATION WAS PROVIDE TO THE TSE, AS THE SURGEON WAS IN THE PROCESS OF CONVERTING TO THE OPEN PROCEDURE. REVIEW OF THE SITE'S SYSTEM LOGS BY THE TSE FOUND THAT SYSTEM ERROR CODE 817 AND SYSTEM ERROR CODE 23024 WERE GENERATED DURING THE SURGICAL PROCEDURE. SYSTEM ERROR CODE 817 OCCURS WHEN THE PSC POWER HAS SWITCHED TO BATTERY POWER. SYSTEM ERROR CODE 23024 OCCURS WHEN THE ECM'S CANNULA SWITCH IS NOT OPERATING PROPERLY. ON (B)(6) 2014, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED AN EVALUATION OF THE SYSTEM AND WAS UNABLE TO DUPLICATE THE SYSTEM ERROR CODES 817 AND 23024 AND MONOPOLAR/BIPOLAR ENERGY ISSUES EXPERIENCED BY THE SITE. FUNCTIONAL TESTING OF THE SITE'S DA VINCI SURGICAL SYSTEM FOUND THAT IT FUNCTIONED WITHIN SPECIFICATIONS. ON (B)(6) 2014, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR). ACCORDING TO THE CSR, HE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE; HOWEVER, HE WAS TOLD BY THE SURGEON THAT DUE TO THE SYSTEM ISSUES THAT OCCURRED DURING THE SURGICAL PROCEDURE, HE MADE THE DECISION TO COMPLETE THE PROCEDURE USING OPEN SURGICAL TECHNIQUES. THE CSR WAS TOLD BY THE SURGEON THAT THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468887 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other