BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3958931 · Received July 28, 2014

    Report

    Report Number
    2955842-2014-04541
    Event Type
    Other
    Date Received
    July 28, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MTML GIMBAL WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE SITE. FUNCTIONAL TESTING OF THE GIMBAL INSTALLED ON AN IN-HOUSE IS3000 MTML WAS PERFORMED. SINE CYCLE TESTING FOR 1 HOUR DID NOT GENERATE ANY ERRORS. THE GIMBAL ALSO PASSED SENSOR TESTING. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO GENERATE THE SYSTEM ERROR CODES 23008 AND 23025 EXPERIENCED BY THE SITE; HOWEVER, REVIEW OF THE SITE'S SYSTEM LOGS SHOWED THAT BOTH SYSTEM ERROR CODES 23025 AND 23008 OCCURRED ON AXIS 7 OF THE GIMBAL. THE MOTOR ENCODER FOR THE AFFECTED AXIS WAS REPLACED AS A PRECAUTION. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE 23008 AND SYSTEM ERROR CODE 23025 APPEAR WHEN THE DA VINCI SI SAFETY SYSTEMS DETERMINE THAT THE ANGULAR POSITION OF ONE OR MORE ROBOTIC JOINTS ON THE SPECIFIED MANIPULATOR, AS MEASURED BY THAT JOINT'S PRIMARY CONTROL SENSOR (ENCODER) AND THE SECONDARY SENSOR (POTENTIOMETER), ARE OUT OF SPECIFIED TOLERANCE FOR AGREEMENT. UPON DETERMINING THESE CONDITIONS, THE SAFETY SYSTEMS PUT THE DA VINCI SI SYSTEM IN A RECOVERABLE SAFE STATE AS OF (B)(4) 2014 THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI CHOLECYSTECTOMY PROCEDURE, THE SURGEON EXPERIENCED SYSTEM FAULTS, CAUSING THE SURGEON TO CONVERT THE PLANNED PROCEDURE TO OPEN SURGICAL TECHNIQUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI CHOLECYSTECTOMY PROCEDURE, THE SITE EXPERIENCED AN UNKNOWN SYSTEM FAULT. THE SITE ATTEMPTED TO RECOVER; HOWEVER, THE LEFT MASTER TOOL MANIPULATOR (MTM) HAD TO BE DISABLED. THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) FOR TECHNICAL SUPPORT ENGINEERING (TSE) ASSISTANCE. WITH THE ASSISTANCE OF THE TSE, THE SITE REMOVED THE INSTALLED INSTRUMENT AND REBOOTED THE SYSTEM. ACCORDING TO THE SITE, THE SYSTEM STARTED UP FINE AND THERE WERE NO ERROR MESSAGES OR ERROR CODES GENERATED. THE TSE WAS TOLD THAT THE SURGEON WAS GOING TO PROCEED WITH THE CASE. APPROXIMATELY 5 MINUTES LATER, THE SITE CONTACTED TECHNICAL SUPPORT ENGINEERING TO REPORT THAT SYSTEM ERROR CODE 23025 OCCURRED. IT WAS REPORTED THAT THE SURGEON RECOVERED FROM THE FAULT AND PROCEEDED WITH THE CASE. REVIEW OF THE SITE'S SYSTEM LOGS BY THE TSE SHOWED THAT MULTIPLE INSTANCES OF SYSTEM ERROR CODE 23008 OCCURRED. DUE TO THE PERSISTENT SYSTEM FAULT, THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED PROCEDURE USING OPEN SURGICAL TECHNIQUES. THERE WAS NO ALLEGATION THAT ANY PATIENT HARM OCCURRED. ON (B)(4) 2014, A FIELD INVESTIGATION WAS PERFORMED BY AN ISI FIELD SERVICE ENGINEER (FSE). THE FSE CONCLUDED THAT THE SYSTEM ERROR CODES 23025 AND SYSTEM ERROR CODE 23008 EXPERIENCED BY THE SITE WERE ASSOCIATED WITH THE LEFT MASTER TOOL MANIPULATOR (MTML) GIMBAL. THE MTM REFERS TO THE MASTER CONTROLLERS WHICH PROVIDE THE MEANS FOR THE SURGEON TO CONTROL THE INSTRUMENTS AND ENDOSCOPE INSIDE THE PATIENT FROM THE SURGEON'S SIDE CONSOLE (SSC). ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). ON (B)(4) 2014, ISI CONTACTED THE ISI CSR WHO REPORTED THIS COMPLAINT. ACCORDING TO THE CSR, THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE REPORTED EVENT AND THE SITE HAS NOT REPORTED TO HER THAT THE PATIENT EXPERIENCED ANY POST-SURGICAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438567 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other