BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3881836 · Received June 18, 2014

    Report

    Report Number
    2955842-2014-03746
    Event Type
    Other
    Date Received
    June 18, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ECM, RAC AND ESSJ WERE RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE SITE. THE FAILURE ANALYSIS RESULTS ARE AS FOLLOWS: A 1 HOUR SINE CYCLE OF THE ECM DID NOT GENERATE ANY ERROR CODES. A (B)(4) FINAL PERFORMANCE TEST WAS ALSO PERFORMED AND THERE WERE NO ERROR CODES GENERATED. A VISUAL INSPECTION OF THE ECM FOUND NO DAMAGE. THE RAC WAS INSTALLED ON AN IN-HOUSE PCA TEST SYSTEM AND WAS POWER CYCLED (B)(4) TIMES. THERE WERE NO FAULTS GENERATED. THE RAC SITTING IDLE FOR HOURS ALSO PASSED FUNCTIONAL TESTING. THE ESSJ WAS INSTALLED ON AN IN-HOUSE PCA SYSTEM AND A (B)(4) SINE CYCLE WAS PERFORMED. THERE WERE NO FAULTS GENERATED. THE ESSJ WAS ALSO POWER CYCLED (B)(4) TIMES AND SAT IDLE FOR (B)(4); HOWEVER, THERE WERE NO FAULTS GENERATED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI CYSTECTOMY PROCEDURE, THE SITE EXPERIENCED PERSISTENT RECOVERABLE FAULTS, CAUSING THE SURGEON TO CONVERT THE PROCEDURE TO OPEN SURGICAL TECHNIQUES. BASED ON THE FAILURE ANALYSIS RESULTS OF THE RETURNED AFFECTED PART IT IS INDETERMINABLE AS TO WHAT CAUSED THE SYSTEM OVERCURRENT FAULT EXPERIENCED BY THE SITE. HOWEVER, SINCE THE OVERCURRENT FAULT WAS CONSISTENT, ISI ENGINEERS BELIEVE THAT THERE WAS A SHORT CIRCUIT CONDITION THAT TRIGGERED THE FAULTS AND THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODES) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. AS OF (B)(4) 2014, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI CYSTECTOMY PROCEDURE, THE SITE EXPERIENCED PERSISTENT RECOVERABLE FAULTS. THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) FOR TECHNICAL SUPPORT ENGINEERING (TSE) ASSISTANCE. WITH THE ASSISTANCE OF THE TSE, THE SITE CYCLE POWERED THE SYSTEM AND THE CIRCUIT BREAKER ON THE VISION SIDE CART (VSC); HOWEVER, THE SITE WAS UNABLE TO RECOVER FROM THE FAULTS. THE TSE THEN INSTRUCTED THE SITE TO CYCLE POWER THE SYSTEM, PERFORM AN EMERGENCY POWER OFF (EPO) AND TURN THE BREAKER SWITCH LOCATED ON THE PATIENT SIDE CART (PSC) TO THE DOWN POSITION. AFTER INSTRUCTING THE SITE TO PERFORM A POWER CYCLE OF THE SYSTEM, A POWER CYCLE OF THE PSC IN STANDALONE MODE AND EXERCISE THE ENDOSCOPIC CAMERA MANIPULATOR (ECM) ARM, IT WAS DISCOVERED THAT ECM PORT CLUTCH WAS NOT RESPONDING. THE ECM IS THE CAMERA ARM LOCATED ON THE PSC, WHICH PROVIDES THE STERILE INTERFACE FOR THE 3D ENDOSCOPE. REVIEW OF THE SITE'S SYSTEM LOGS BY THE TSE FOUND THAT SYSTEM ERROR CODES 25513 AND 25553 OCCURRED, INDICATING THAT THERE WAS AN ISSUE WITH THE ECM SUBSYSTEM CAUSING AN OVERCURRENT ERROR. UNABLE TO RESOLVE THE ISSUE AND PRIOR TO CONTACTING ISI FOR TECHNICAL SUPPORT ASSISTANCE, THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO PATIENT HARM WAS REPORTED. ON (B)(4) 2014, ISI CONTACTED THE ISI CLINICAL SALES REPRESENTATIVE (CSR) REGARDING THE REPORTED EVENT. ACCORDING TO THE CSR HE WAS NOT PRESENT DURING THE SURGICAL PROCEDURE. THE CSR INDICATED THAT THE SURGEON WAS HALF WAY THROUGH THE SURGICAL PROCEDURE WHEN HE WAS CONTACTED BY THE SITE REGARDING THE SYSTEM FAULT. HE WAS TOLD BY THE SITE THAT THEY MADE MULTIPLE UNSUCCESSFUL ATTEMPTS TO RECOVER FROM THE SYSTEM FAULTS. THE CSR INDICATED THAT WHILE HE WAS ON THE TELEPHONE WITH THE SITE, THE SITE POWER CYCLED THE SYSTEM; HOWEVER, THE ISSUE PERSISTED. THE CSR THEN INSTRUCTED THE SITE TO CONTACT ISI FOR TECHNICAL SUPPORT ASSISTANCE. ON (B)(4) 2014, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION AT THE SITE. THE FSE WAS UNABLE TO DUPLICATE THE OVERCURRENT FAULT EXPERIENCED BY THE SITE. THE FSE POWERED THE SYSTEM ON MULTIPLE TIMES AND THERE WERE NO ISSUES NOTED. HOWEVER, AS A PRECAUTION, THE FSE REPLACED THE ECM AND ITS RELATED SUBSYSTEM PARTS: A REMOTE ARM CONTROLLER (RAC) AND AN EMBEDDED SERIALIZER SETUP JOINT (ESSJ).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357939 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other