BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3275500 · Received August 9, 2013

    Report

    Report Number
    2955842-2013-02991
    Event Type
    Other
    Date Received
    August 9, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONDUCTED BY THE FIELD SERVICE ENGINEER CONCLUDED THAT SYSTEM ERROR CODE 212 EXPERIENCED BY THE CUSTOMER WAS ASSOCIATED WITH THE LEFT MASTER TOOL MANIPULATOR (MTML) AND THE MULTIPLE SERVO DRIVER (MSD) PCA BOARD. 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 SIDE CONSOLE. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). THE SYSTEM CONTAINS FIVE MULTIPLE SERVO DRIVER (MSD) PCA BOARDS, WHICH PROVIDE DRIVE CURRENT TO THE SERVO MOTORS ASSOCIATED WITH EACH DEGREE OF FREEDOM. THE SYSTEM WAS REPAIRED BY REPLACING THE AFFECTED MTML AND MSD PCA BOARD. THE SYSTEM ALARM (SYSTEM GENERATED FAULT CODE) FUNCTIONED AS DESIGNED AND THERE WAS NO INJURY TO THE PATIENT. SYSTEM ERROR CODE 212 OCCURS WHEN THE ACTUAL VOLTAGE TO DRIVE CURRENT THROUGH THE MOTORS DEVIATES FROM THE EXPECTED VOLTAGE BY A SPECIFIED AMOUNT. UPON DETERMINING THIS CONDITION, THE SAFETY SYSTEMS PUT THE DA VINCI IN A NON-RECOVERABLE SAFE STATE. THE MTML AND THE MSD BOARD WERE RETURNED TO INTUITIVE SURGICAL, INC.(ISI) FOR FAILURE ANALYSIS INVESTIGATION. ENGINEERING CONFIRMED THE CUSTOMER REPORTED SYSTEM ERROR CODE 212 AND FOUND THAT THE MAIN CABLE HARNESS AND AXIS 3 MOTOR WERE DEFECTIVE. THE MSD BOARD OUTPUT WAS FOUND TO BE OUT OF THE ACCEPTABLE RANGE. AS OF (B)(6) 2013, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE SURGEON MADE THE DECISION TO CONVERT TO OPEN SURGICAL TECHNIQUES AFTER ENCOUNTERING AN RECURRING SYSTEM ERROR CODE 212 WITH THE DA VINCI S SURGICAL SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROSTATECTOMY PROCEDURE, THE CUSTOMER EXPERIENCED NON-RECOVERABLE SYSTEM ERROR CODE 212. WITH THE ASSISTANCE OF AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE), THE SITE REMOVED THE INSTRUMENT INSTALLED ON THE PATIENT SIDE MANIPULATOR (PSM) ARMS AND POWERED OFF THE SYSTEM. WHEN THE SITE RESTARTED THE SYSTEM, THE ISSUE RECURRED. THE TSE INSTRUCTED THE SITE TO EXERCISE THE LEFT MASTER TOOL MANIPULATOR (MTML) ON THE SURGEON SIDE CART AND PERFORM A FAULT OVERRIDE; HOWEVER, SYSTEM ERROR CODE 212 RECURRED. UNABLE TO RESOLVE THE ISSUE THE SURGEON MADE THE DECISION TO ABORT THE PLANNED SURGICAL PROCEDURE. NO PATIENT HARM WAS REPORTED ON (B)(6) 2013, ISI CONTACTED THE SITE'S OR UNIT ASSISTANT. THE OR UNIT ASSISTANT INDICATED THAT THE PLANNED SURGICAL PROCEDURE WAS COMPLETED USING OPEN SURGICAL TECHNIQUES. SHE INDICATED THAT SHE WAS UNABLE TO PROVIDE ANY OTHER DETAILS REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380316 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DA VINCI S SURG SYSTEM INSTRUMENTS AND ACCESSORIE