BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3714272 · Received March 31, 2014

    Report

    Report Number
    2955842-2014-01860
    Event Type
    Other
    Date Received
    March 31, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE CFG,RAC-09 INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS COULD NOT REPLICATE THE CUSTOMER REPORTED FAILURE MODE OF AN ERROR 25326 BY INSTALLING THIS BOARD INTO AN PRINTED CIRCUIT ASSEMBLY (PCA) SYSTEM AND RUNNING A 10 MINUTE SINE CYCLE IN - HOUSE, 20X POWER CYCLES, AND SITTING IDLE FOR 1 HOUR. THE SYSTEM PASSED WITHOUT ANY ERRORS.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE PSM2 OR THE RAC INVOLVED WITH THIS COMPLAINT. THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. ISI CONTACTED THE INITIAL REPORTER OF THIS COMPLAINT ON 03/23/2014: THE INITIAL REPORTER CONFIRMED THAT THE ERROR 25326 WAS NOTICED DURING THE SETUP OF THE DA VINCI SYSTEM, PRIOR TO THE SURGERY. THE PATIENT WAS ALREADY UNDER ANESTHESIA AND PORTS HAD NOT BEEN PLACED ON THE PATIENT AT THE TIME. DUE TO THE ERROR MESSAGE, THE SURGEON DECIDED TO PERFORM AN OPEN RADICAL RETROPUBIC PROSTATECTOMY PROCEDURE AFTER SPEAKING TO THE PATIENT'S SPOUSE. THE PATIENT TOLERATED THE OPEN PROCEDURE WELL AND WAS DISCHARGED ON (B)(6) 2014. THE ERROR MESSAGE WAS RESOLVED BY REPLACEMENT OF THE 3RD ARM. NO FURTHER CLINICAL INFORMATION WAS PROVIDED BY THE SITE. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2014 AND CONFIRMED THAT THE ERROR CODE 25326 AND 23022 OCCURRED THAT DAY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DUE TO THE ERROR CODE 25326, THE SURGEON MADE THE DECISION TO CONVERT THE DA VINCI PROCEDURE TO OPEN SURGICAL TECHNIQUES.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PATIENT SIDE MANIPULATOR 2 (PSM2) BACK INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO DUPLICATE THE ALLEGED ERROR CODE 23002 FOR AXIS 2 AS INDICATED BY THE INITIAL REPORTER. NO TROUBLE WAS FOUND WITH THE PSM2. THE ERROR CODE 25326 MENTIONED WAS NOT AN ARM FAULT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE REMOTE ARM CONTROLLER (RAC) FOR THE ERROR CODE 25326 ISSUE. THE ARM PASSED MULTIPLE BRAKE TEST RUNS AND THE ADVANCED BRAKE TEST. THE ARM ALSO PASSED AN IN-HOUSE BRAKE DROP TEST FOR AXIS-2.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 5 MINUTES PRIOR TO THE START OF A DA VINCI SURGICAL RADICAL PROSTATECTOMY PROCEDURE, THE SURGICAL STAFF ENCOUNTERED ERROR CODES 25326 AND 23022. AN ERROR 25326 IS A NON- RECOVERABLE EMERGENCY TRIGGERED DUE TO COMMUNICATION TIMEOUT IN REMOTE ARM CONTROLLER. AN ERROR CODE 23022 IS A RECOVERABLE BRAKE TEST ERROR. DUE TO THE ERROR CODE ISSUE, THE SURGEON DECIDED TO CONVERT THE DA VINCI PROCEDURE TO OPEN SURGICAL TECHNIQUE. AT THIS TIME THERE IS NO INFORMATION ON THE PATIENT'S CONDITION OR HOW THE PATIENT TOLERATED THE OPEN PROCEDURE. AN INTUITIVE SURGICAL INC. (ISI) FIELD SERVICE ENGINEER (FSE) VISITED THE SITE THE SAME DAY AND PERFORMED A FIELD EVALUATION. THE FSE REPAIRED THE DA VINCI SYSTEM BY REPLACING THE REMOTE ARM CONTROLLER 2 (RAC) AND THE PATIENT SIDE MANIPULATOR 1(PSM).THE FSE PERFORMED SYSTEM VERIFICATION TEST AND AN ELECTRICAL TEST AND THE SYSTEM PASSED TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189137 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P8

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other