BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3172872 · Received June 17, 2013

    Report

    Report Number
    2955842-2013-02184
    Event Type
    Other
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 17, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013, PRODUCT CAME BACK FOR INVESTIGATION AND FAILURE ANALYSIS (FA) WAS UNABLE TO REPRODUCE ERROR 40006 BY INSTALLING THE BOARD INTO PCA SYSTEM AND RUNNING 10 MINUTES SINCE CYCLE, X 30 POWER CYCLES AND SITTING IDLE FOR AN HOUR.BASED ON ENGINEERING'S RECOMMENDATION, THE UNIT NEEDED TO BE REPLACED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 A SURGICAL TECHNICAL ASSISTANT CONTACTED ISI TECHNICAL SUPPORT FOR A NON-RECOVERABLE ERROR MESSAGE 40006 THAT HAPPENED DURING SYSTEM START USING DA VINCI SI SURGICAL PROCEDURE. AN ERROR 40006 MEANS THAT THERE WAS A COMMUNICATION ERROR INTERNALLY IN THE SYSTEM. THE SURGICAL ASSISTANCE MENTIONED THAT THE PATIENT WAS UNDER ANESTHESIA WITH NO INCISIONS PLACED. ISI TECHNICAL SUPPORT HAD THE SITE EMERGENCY POWER OFF (EPO), SYSTEM RESTART AND HAD THE SITE EXERCISE MASTER TOOL MANIPULATOR RIGHT (MTMR). THE SURGEON DECIDED TO RESCHEDULE THE SURGERY FOR THE FOLLOWING DAY. ISI TECHNICAL SUPPORT LOOKED INTO THE SYSTEM LOG AND NOTICED SEVERAL ERROR 40006 AND 25326 POINTING TOWARD THE MTMR. ERROR 25326 MEANS COMMUNICATION TIMED- OUT AND IS WAITING FOR A RESPONSE FROM A REMOTE COMPUTE ENGINE (RCE). ISI REGULATORY COMPLAINT ANALYST SENT FOLLOW UP QUESTIONS AND OBTAINED THE FOLLOWING INFORMATION: A MALE PATIENT WAS GOING IN FOR A ROBOTIC ASSISTED RADICAL PROSTATECTOMY PROCEDURE ON (B)(6) 2013. THE PATIENT WAS UNDER ANESTHESIA AND APPROXIMATELY 2 HOURS AND 4 MINUTES INTO THE SURGERY THE DA VINCI SI SYSTEM DISPLAYED A NON-RECOVERABLE ERROR MESSAGE 40006. IT WAS CONFIRMED BY THE SURGICAL TECHNICAL SUPPORT THAT THERE WAS NO PORTS PLACED ON THE PATIENT. THERE WERE NO COMPLICATIONS ON THE PATIENT DUE TO THE ALLEGED ISSUE. THE SURGEON DECIDED TO STOP THE PROCEDURE AND START THE PROCEDURE AGAIN THE FOLLOWING MORNING DUE TO THE ALLEGED ERROR MESSAGES. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE REMOTE ARM CONTROLLER BOARDS (RAC) AND PERFORMED A SYSTEM VERIFICATION TEST AND TEST WAS OK. AN ELECTRICAL SAFETY TEST WAS ALSO PERFORMED AND THE TEST WAS OK. ISSUE WITH THE ALLEGED ERROR MESSAGES WAS RESOLVED. THE ALLEGED ERROR MESSAGES WERE CAUSED FROM THE REMOTE ARM CONTROLLER BOARDS (RAC). THE PATIENT HAD THE SURGERY THE FOLLOWING DAY USING THE DA VINCI SI SYSTEM WITH NO COMPLICATIONS. THE PATIENT STATUS WAS IN GOOD CONDITION AFTER THE PROCEDURE. THE COMPLAINT IS BEING REPORTED DUE TO THE FACT THAT THE SURGEON ABORTED THE DA VINCI SI SYSTEM DUE TO THE ALLEGED ERROR MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273354 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES