BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 4030549 · Received August 22, 2014

    Report

    Report Number
    2955842-2014-05136
    Event Type
    Other
    Date Received
    August 22, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 15, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUJC HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE ACCESSORY IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2014 AND CONFIRMED THAT THE ERROR CODES WERE FOUND TO HAVE OCCURRED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DUE TO THE REPORTED ERROR MESSAGES, THE SURGEON MADE THE DECISION TO ABORT THE DA VINCI SURGICAL PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE SET UP JOINT WAS RETURNED WITH THE FOLLOWING FINDINGS: DURING VISUAL INSPECTION, NO DAMAGE WAS OBSERVED ON THE HARNESS EXCEPT FOR WHERE THE HARNESS BENDS AT THE BOTTOM OF THE AXLE SHOULDER FLANGE. IT WAS AN ELECTRICAL PROBLEM WHICH COULD HAPPEN WHEN MOVING Z-AXIS NUMEROUS TIMES AND POSSIBLY A SHORT ON THE CABLE HARNESS. FAILURE ANALYSIS WAS ABLE TO DUPLICATE ONE OF THE REPORTED ISSUES. THE SUJ CABLE HARNESS FAULTED WHILE WIGGLING IN AN UP AND DOWN MOTION DURING SINE CYCLE. THIS WAS WHEN THE SUJ SHOWED THESE TYPES OF FAULTS. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING CLASSIFIED AS NON-REPORTABLE DUE TO THE FOLLOWING CONCLUSIONS: THE REPORTED ABORTION OF THE DA VINCI SURGICAL PROCEDURE DOES NOT MEET ISI'S CRITERIA FOR A SERIOUS INJURY AND IS NOT CONSIDERED MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. RECURRENCE OF THE ALLEGED FAILURE MODE IS NOT EXPECTED TO CAUSE OR CONTRIBUTE TO A DEATH, SERIOUS INJURY OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF A PATIENT. BASED ON THIS ADDITIONAL FAILURE ANALYSIS INVESTIGATION INFORMATION, THIS MDR REPORT IS BEING RETRACTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI CYSTECTOMY PROCEDURE, THE SURGICAL STAFF OBTAINED AN ERROR CODE 297 WHEN DOCKING THE DA VINCI SURGICAL SYSTEM TO THE PATIENT. SYSTEM ERROR CODE 297 APPEARS WHEN THE SYSTEM DETECTS THAT AN ELECTRONIC COMPONENT WAS REPORTING AN INCORRECT CONFIGURATION. UPON DETERMINING THIS CONDITION, THE SYSTEM RECORDS THE FAULT AND TRANSITIONS TO A SAFE STATE. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. THE SURGICAL STAFF REBOOTED THE SYSTEM THREE TIMES AND WAS UNABLE TO CLEAR THE FAULT. THE INITIAL REPORTER OF THIS COMPLAINT CONTACTED, INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) FOR ASSISTANCE. THE TSE REVIEWED THE SYSTEM LOGS AND NOTED THERE WERE SEVERAL ERROR CODES: 23 ON ARMNET3, FOLLOWED BY ERROR CODE 288, AND ERROR CODE 40068 ON THE SAME ARMNET. AN ERROR CODE 23 INDICATES A NODE REPORTED A HARDWARE FAULT IN THE WHEEL COMMUNICATION. AN ERROR CODE 288 INDICATES THAT A TIMER WAS SET FOR A SYSTEM ACTION TO COMPLETE AND IT TIMED OUT. AN ERROR CODE 40068 MEANS A RESPONSE HAD A STATUS THAT REFLECTED A FAILED COMMAND. THE TSE EXPLAINED TO THE INITIAL REPORTER THAT THE ERROR CODE 297 WAS CRITICAL AND THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) ARM CANNOT BE DISABLED. THE INITIAL REPORTER ASKED THE TSE WHETHER THIS CASE CAN CONTINUE USING THE DA VINCI SURGICAL SYSTEM AND THE TSE ADVISED THAT THEY SHOULD TRY TO CLEAR THE FAULT BY MOVING THE SET UP JOINT CONTROLLER (SUJC) AROUND, LEAVING IT IN A DIFFERENT POSITION, AND REBOOTING THE SYSTEM. THE INITIAL REPORTER TOOK THE ADVICE OF THE TSE, THE ERROR CODES CLEARED, AND SHE WAS ABLE TO MOVE THE SUJC WITH FULL RANGE OF MOTION AND DID NOT RECEIVE ANY ERROR MESSAGES. THE INITIAL REPORTER CONTACTED THE TSE BACK STATING THAT THEY WERE GETTING FREQUENT ERROR MESSAGES AND THE SURGEON MADE THE DECISION TO ABORT THE CASE. AN ISI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE ON (B)(4) 2014 AND NOTED THAT THE ERROR CODE 23 WAS POINTING TO THE SUJ ON THE CAMERA. THE FSE REPAIRED THE SYSTEM BY REPLACING THE SUJC AND THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ON (B)(4) 2014, ISI CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION: THE SYSTEM WAS TESTED PRIOR TO USE AND NO ERRORS OCCURRED AT THE TIME OF THE SET UP. THERE WERE APPROXIMATELY 6 PORTS PLACED IN THE PATIENT. THE SURGICAL STAFF WAS ABOUT TO DOCK THE SYSTEM WHEN THEY ENCOUNTERED THE REPORTED ERROR CODES. THE PATIENT WAS UNDER ANESTHESIA FOR APPROXIMATELY 45 MINUTES WHEN THE SURGEON MADE THE DECISION TO ABORT THE CASE. THE PATIENT HAS NOT BEEN RESCHEDULED AT THIS TIME FOR THE CYSTECTOMY PROCEDURE. THE SYSTEM HAS BEEN USED AFTER THE REPLACEMENT OF THE SUJC AND THE SITE HAS NOT REPORTED ANY FURTHER PROBLEMS WITH THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509285 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other