BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3951486 · Received July 22, 2014

    Report

    Report Number
    2955842-2014-04491
    Event Type
    Other
    Date Received
    July 22, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    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

    THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. AN ERROR 23013 MEANS THE POTENTIOMETER AND ENCODER ARE NOT TRACKING EACH OTHER PROPERLY; THE PROBLEM IS USUALLY CAUSED BY EITHER THE POTENTIOMETER OR THE ENCODER (OR ASSOCIATED WIRING) BEING FAULTY. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2014 AND CONFIRMED THAT THE SYSTEM ERROR CODE 23013 WAS FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DUE TO THE ALLEGED ERROR CODE 2013, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI PROCEDURE TO AN OPEN PROCEDURE.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PSM INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATION WAS ABLE TO VERIFY IN THE SYSTEM ERROR LOG THAT ERROR CODE 23013 HAD OCCURRED; HOWEVER, THE ERROR CODE COULD NOT BE DUPLICATED WITH THE EVALUATION OF THE PSM. THE ARM PASSED TESTING. A SENSORS TEST SHOWED NOTHING UNUSUAL. ALL PLOTS AND READOUTS WERE WELL WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PULMONARY LOBECTOMY PROCEDURE, THE SITE ENCOUNTERED AN ERROR 23013 MESSAGE. DUE TO THE REPORTED ERROR MESSAGE THE SURGEON MADE THE DECISION TO CONVERT THE PROCEDURE TO AN OPEN PROCEDURE. ON (B)(4) 2014, AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND REPAIRED THE SYSTEM BY REPLACING THE PATIENT SIDE MANIPULATOR 3. THE PATIENT SIDE MANIPULATOR IS AN INSTRUMENT ARM LOCATED ON THE PATIENT SIDE CART,THAT PROVIDES THE STERILE INTERFACE FOR THE ENDOWRIST INSTRUMENTS. ON (B)(4) 2014 ISI CONTACTED THE SITE AND OBTAINED THE FOLLOWING INFORMATION: LESS THAN 30 MINUTES INTO THE PROCEDURE, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI PROCEDURE TO OPEN SURGERY DUE TO THE ALLEGED ERROR 23013 FAULTING ON PSM3 ARM. THE PATIENT TOLERATED THE OPEN PROCEDURE AND WAS DISCHARGED 7 DAYS LATER. THE PATIENT HAS NOT RETURNED BACK TO THE HOSPITAL WITH COMPLAINTS OF POST- SURGICAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429003 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other