BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3900839 · Received June 27, 2014

    Report

    Report Number
    2955842-2014-03969
    Event Type
    Other
    Date Received
    June 27, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MTML WAS RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. FAILURE ANALYSIS INVESTIGATION WAS ABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE SITE. FUNCTIONAL TESTING OF THE MTML WAS ABLE TO GENERATE SYSTEM ERROR CODE 23009 AND SYSTEM ERROR CODE 23013 AS AN AXIS ON THE MTML FAILED A CHECK SENSOR TEST WHILE BACK DRIVING THE MTML. THE MAIN CABLE HARNESS WAS ALSO FOUND TO HAVE AN INTERMITTENT PROBLEM. THE AXIS MOTOR AND HARNESS WERE REPLACED TO REPAIR THE MTML. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE 23009 AND SYSTEM ERROR CODE 23013 APPEAR WHEN THE DA VINCI S SAFETY SYSTEMS DETERMINES 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), WERE OUT OF SPECIFIED TOLERANCE FOR AGREEMENT. UPON DETERMINING THESE CONDITIONS, THE SAFETY SYSTEMS PUT DA VINCI S IN A RECOVERABLE SAFE STATE. AS OF (B)(6) 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 PROSTATECTOMY 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 PROSTATECTOMY PROCEDURE, THE SITE EXPERIENCED SYSTEM ERROR CODE 23013. THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) FOR TECHNICAL SUPPORT ENGINEERING (TSE) ASSISTANCE. REVIEW OF THE SITE'S SYSTEM LOGS BY THE TSE FOUND THAT MULTIPLE INSTANCES OF SYSTEM ERROR CODE 23013 OCCURRED. THE TSE ALSO FOUND THAT SYSTEM ERROR CODE 23008 OCCURRED. WITH THE ASSISTANCE OF THE TSE, THE SITE PERFORMED AN EMERGENCY POWER OFF (EPO) AND CYCLE POWERED THE SYSTEM; HOWEVER, THE ISSUE PERSISTED. UNABLE TO RESOLVE THE ISSUE, THE SURGEON MADE THE DECISION TO COMPLETE THE PLANNED PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO PATIENT HARM WAS REPORTED. ON (B)(4) 2014, A FIELD INVESTIGATION WAS PERFORMED BY AN ISI FIELD SERVICE ENGINEER (FSE). THE FSE CONCLUDED THAT THE SYSTEM ERROR CODE 23013 AND SYSTEM ERROR CODE 23008 EXPERIENCED BY THE SITE WERE ASSOCIATED WITH THE LEFT MASTER TOOL MANIPULATOR (MTML). THE FSE ALSO FOUND THAT THE SITE EXPERIENCED SYSTEM ERROR CODE 23009. THE MASTER TOOL MANIPULATOR 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). THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED MTML. ON (B)(6) 2014, THE INITIAL REPORTER OF THIS COMPLAINT PROVIDED ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. ACCORDING TO THE INITIAL REPORTER, 5 MINUTES AFTER STARTING THE ROBOTIC PROCEDURE, THE SURGEON SENSED THAT THE MTM WAS WRONG. THE SURGEON MADE THE DECISION TO CONVERT THE PLANNED PROCEDURE TO OPEN SURGICAL TECHNIQUES AFTER 30 MINUTES. THERE WERE NO ISSUES NOTED DURING SET UP OF THE SYSTEM FOR THE SURGICAL PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY INTRA-OPERATIVE OR POST-SURGICAL COMPLICATIONS AS A RESULT OF UNDERGOING THE OPEN SURGICAL PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT IS REPORTED TO BE IN STABLE CONDITION AND HAS NOT EXPERIENCED ANY PROBLEMS AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378164 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other