BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3924458 · Received July 9, 2014

    Report

    Report Number
    2955842-2014-04197
    Event Type
    Other
    Date Received
    July 9, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MTML WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION CONFIRMED THE CUSTOMER REPORTED FAILURE MODE AS SYSTEM ERROR CODE 23008 WAS REPLICATED ON AN IN-HOUSE IS3000 SYSTEM. THE CALIBRATION GRIP VALUES WERE FOUND TO BE OUT OF SPECIFICATIONS, THUS CAUSING THE ISSUES EXPERIENCED BY THE SITE. RE-CALIBRATION OF THE MTML WAS PERFORMED TO REPAIR THE MTML. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI NEPHRECTOMY PROCEDURE, THE SITE EXPERIENCED A PERSISTENT RECOVERABLE SYSTEM ERROR CODE 23008, CAUSING THE SURGEON TO CONVERT TO AN OPEN PROCEDURE. 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 SI SAFETY SYSTEM 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 PUTS DA VINCI SI IN A RECOVERABLE SAFE STATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI NEPHRECTOMY PROCEDURE, THE SITE EXPERIENCED MULTIPLE OCCURRENCES OF RECOVERABLE SYSTEM ERROR CODE 23008. THE SITE CONTACTED INTUITIVE SURGICAL, INC. (ISI) FOR TECHNICAL SUPPORT ENGINEERING (TSE) ASSISTANCE. WITH THE ASSISTANCE OF THE TSE, THE SITE POWER CYCLED THE SURGEON SIDE CART (SSC); HOWEVER, SYSTEM ERROR CODE 23008 RECURRED AS THE SURGEON WENT INTO FOLLOWING MODE. THE SITE REPORTED THAT THE SURGEON WAS GOING TO PERFORM THE PLANNED PROCEDURE USING PATIENT SIDE MANIPULATOR (PSM) ARM 1 AND 3. AFTER SOME TIME OF USE, THE SITE CONTACTED ISI TSE TO REPORT THAT THE SURGEON WAS UNABLE TO OPEN THE JAWS OF AN INSTRUMENT THAT WAS GRIPPING TISSUE DUE TO THE PERSISTENT SYSTEM FAULT. WITH THE ASSISTANCE OF THE TSE, THE SITE USED THE EMERGENCY WRENCH TO RELEASE THE JAWS OF THE INSTRUMENT FROM THE PATIENT'S TISSUE. THE SURGEON MADE THE DECISION TO COMPLETE THE PROCEDURE USING OPEN SURGICAL TECHNIQUES. NO PATIENT HARM WAS REPORTED. ON (B)(6) 2014, AN ISI FIELD SERVICE ENGINEER (FSE) PERFORMED A FIELD EVALUATION OF THE SYSTEM. DURING THE FSE'S INVESTIGATION, A REVIEW OF THE SITE'S SYSTEM LOGS WAS PERFORMED AND THE OCCURRENCE OF SYSTEM ERROR CODE 23008 WAS CONFIRMED. THE FSE DETERMINED THAT THE SYSTEM ERROR CODE 23008 EXPERIENCED BY THE SITE WAS ASSOCIATED WITH THE LEFT MASTER TOOL MANIPULATOR (MTML). 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 SSC. ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML) AND ONE TO HIS RIGHT (MTMR). THE FSE REPLACED THE MTML AND RECALIBRATED THE SYSTEM'S GRAVITY COMPENSATION TO REPAIR THE SYSTEM. ON JUNE 20, 2014, ISI CONTACTED THE SITE'S REGIONAL MANAGER FOR SURGICAL SERVICES. ACCORDING TO THE REGIONAL MANAGER, THE SURGEON MADE THE DECISION TO COVERT THE PLANNED PROCEDURE TO OPEN DUE TO THE PERSISTENT SYSTEM ERROR CODE 23008. THE REGIONAL MANAGER INDICATED THAT TO THE BEST OF HER KNOWLEDGE THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS DURING THE OPEN PROCEDURE. ON (B)(4) 2014, ISI CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT. ACCORDING TO THE INITIAL REPORTER, SYSTEM ERROR CODE 23008 RECURRED AND THEN THE SURGEON WAS UNABLE TO OPEN THE GRIPS ON AN INSTALLED INSTRUMENT, CAUSING THE SURGEON TO CONVERT THE PROCEDURE TO OPEN SURGICAL TECHNIQUES. THE INITIAL REPORTER INDICATED THAT TO THE BEST OF HER KNOWLEDGE THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE REPORTED EVENT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401980 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other