BEUDAMED
    FDA Adverse Event Other Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 3900827 · Received June 27, 2014

    Report

    Report Number
    2955842-2014-03968
    Event Type
    Other
    Date Received
    June 27, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MTM HAS NOT BEEN RETURNED FOR EVALUATION. 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 HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(4) 2014 AND CONFIRMED THAT ERROR CODE 23013 WAS FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. AN ERROR CODE 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. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DUE TO THE ERROR CODE 23013 DURING THE DA VINCI PROSTATECTOMY PROCEDURE, THE SURGEON MADE THE DECISION TO ABORT THE PROCEDURE POST- ANESTHESIA.

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE MASTER TOOL MANIPULATOR (MTM) INVOLVED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE INITIAL REPORTER'S COMPLAINT. THE ERROR CODE 23013 WAS REPLICATED DURING A SINE CYCLE TEST. AXIS 1 POT FAILED THE CHECK SENSOR TEST WITH A HIGH POT JITTER. THE LARGE BEARINGS ON THE AXIS 2 BICEP ASSEMBLY WAS SQUEAKING AND WAS CAUSING AXIS 2 TO FAIL THE FRICTION TEST. DUE TO THE BAD BEARINGS, THE MTM WAS BEYOND REPAIR. NO REPAIRS WERE PERFORMED ON THE MTM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI PROSTATECTOMY PROCEDURE, THE SITE EXPERIENCED AN ERROR CODE 23013 MULTIPLE TIMES DURING THE PROCEDURE. PER THE INITIAL REPORTER, THE SITE WAS EXPERIENCING THE ERROR MESSAGE EVERY 2-3 SECONDS. THE SURGEON HAD TO PRESS THE FAULT OVERRIDE EVERY TIME TO CONTINUE WITH THE SURGERY. DUE TO THE ALLEGED ISSUE, THE SURGEON MADE THE DECISION TO ABORT THE PROCEDURE POST- ANESTHESIA. ON THE DAY OF THE EVENT OF THIS COMPLAINT, THE INITIAL REPORTER SPOKE TO THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THE SYSTEM LOGS WERE REVIEWED AND IT WAS NOTED THAT THE ALLEGED ERROR CODE 23013 WAS POINTING TO THE RIGHT MASTER TOOL MANIPULATOR (MTM) AXIS. 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 ONE TO HIS RIGHT (MTMR). ISI CONTACTED THE INITIAL REPORTER AND OBTAINED THE FOLLOWING INFORMATION ON (B)(4) 2014: THE SYSTEM WAS TESTED PRIOR TO USE AND NO PROBLEMS WERE NOTED DURING SET UP OF THE DA VINCI SYSTEM. THE PATIENT WAS UNDER ANESTHESIA WITH PORT PLACEMENT FOR ABOUT AN HOUR. THERE WAS NO INJURY TO THE PATIENT DUE TO BEING UNDER ANESTHESIA. THE ERROR 23013 OCCURRED EARLY IN THE PROCEDURE AND CONTINUED TO DISPLAY EVERY COUPLE OF SECONDS ON THE SCREEN, WHICH MADE THE SURGERY HARD TO CONTINUE USING THE DA VINCI; THEREFORE, THE SURGEON MADE THE DECISION TO ABORT THE PROCEDURE. ON (B)(6) 2014, THE MTM WAS REPLACED AND THE PATIENT WAS RESCHEDULED FOR SURGERY ON (B)(6) 2014. THE PATIENT'S CURRENT STATUS IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377340 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS2000 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other