BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1182394 · Received September 22, 2008

    Report

    Report Number
    2955842-2008-01282
    Event Type
    Other
    Date Received
    September 22, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 22, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THAT SYSTEM ERROR CODES #23008 AND #212 WERE ASSOCIATED WITH THE LEFT MASTER TOOL MANIPULATOR AND/OR THE INPUT OUTPUT DISTRIBUTION BOARD (IODG PCA). 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. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND TO HIS RIGHT (MTMR). THE PURPOSE OF THE IODG PCA IS TO INTERFACE ALL EXTERNAL INPUT/OUTPUT TO THE INTERNAL SYSTEM ELECTRONICS. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED MTML AND IODG PCA. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE #23008 APPEARS 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 THIS CONDITION, THE SAFETY SYSTEM PUT DAVINCI IN A "RECOVERABLE SAFE STATE". SYSTEM ERROR CODE #212 OCCURS WHEN THE ACTUAL VOLTAGE TO DRIVE CURRENT THROUGH THE MOTORS DEVIATES FROM THE EXPECTED VOLTAGE BY A SPECIFIED AMOUNT. SINCE THE MOTOR'S VELOCITY IS A COMPONENT OF THE EXPECTED VOLTAGE CALCULATION, THIS ERROR CAN BE CAUSED BY A FAULTY ENCODER. THE MTML AND IODG PCA WERE RETURNED TO ISI FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING EVALUATION FOUND NO ISSUES WITH THE IODG PCA, HOWEVER, DURING EVALUATION OF THE MTML, ENGINEERING FOUND THAT A MOTOR ENCODER HAD MALFUNCTIONED, THUS GENERATING THE SYSTEM ERRORS EXPERIENCED BY THE CUSTOMER. AS OF 2008, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE INSERTING INSTRUMENTS INTO THE PATIENT DURING THE BEGINNING OF A DA VINCI S PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER EXPERIENCED SYSTEM ERROR CODES #23008 AND #212. THE SYSTEM WAS RESTARTED, HOWEVER, THE ERROR CODES RECURRED WHEN ATTEMPTING TO HOME THE SYSTEM. WITH THE ASSISTANCE OF AN ISIS TECHNICAL SUPPORT ENGINEER, THE CUSTOMER SHUT DOWN THE SYSTEM AND EXERCISED THE LEFT MASTER TOOL MANIPULATOR. THE SYSTEM WAS RESTARTED AND THE SYSTEM ERROR CODES REAPPEARED DURING HOMING. THE SURGEON DECIDED TO ABORT THE PLANNED SURGICAL PROCEDURE AND NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. IS2000 A5.1P6

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SURGICAL SYSTEM INSTRUMENTS| ACCESSORIES