BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 10268758 · Received July 13, 2020

    Report

    Report Number
    2955842-2020-10639
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    June 8, 2020
    Report Date
    June 16, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110744
    PMA / PMN Number
    K131861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE REPORTED COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION. THE FSE REPLACED THE MEDICAL GRADE POWER SUPPLY (MGPS) AND THE GUIDED CAMERA CHANGE (GCC) WITH NO CHANGE. IT WAS NOTED THAT BOTH REMOTE ARM CONTROLLERS (RACS) WERE MISSING 48 VOLTS. THEN THE FSE REPLACED THE GENERIC POWER DISTRIBUTOR (GPD) AND RECHECKED ALL CONNECTIONS, AGAIN WITH NO RESOLUTION. IT WAS NOTED THAT 48 VOLT STATUS LEDS ELSEWHERE WERE LIT. THE FSE REPLACED RAC 1 AND THE ISSUE WAS RESOLVED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE REMOTE ARM CONTROLLER (RAC), GUIDED CAMERA CHANGE (GCC), AND GENERIC POWER DISTRIBUTOR (GPD) PARTS INVOLVED WITH THIS COMPLAINT AND COMPLETED PRODUCT EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION REPLICATED THE REPORTED COMPLAINT ON THE RAC. THE RAC WAS INSTALLED AND TESTED IN THE TEST SYSTEM. AT START-UP, THE RAC FAILED WITH ERROR 25551 WHICH INDICATED THE POWER-ON SELF-TEST FAILED. THE RAC CONTROL MODULE (RCM) FAILED. THE GUIDED CAMERA CHANGE (GCC) WAS INSTALLED AND TESTED WITH THE RAC THAT WAS RETURNED, AND IT FAILED WITH ERROR 25551 INDICATING POWER-ON SELF-TEST FAILED. NO TROUBLE WAS FOUND WITH THE GCC BOARD. THE GPD WAS INSTALLED INTO THE TEST SYSTEM AND RAN 10 MINUTES OF SINE CYCLE, 10 POWER CYCLES, AND SAT IDLE FOR ONE HOUR WITH NO TROUBLE FOUND. BASED ON THE INVESTIGATION PERFORMED, THE TECHNICAL SERVICE ENGINEER (TSE) CONFIRMED ERROR 2551 POINTED TO THE RIGHT MASTER TOOL MANIPULATOR (MTMR). THE MTMS ARE THE MANIPULATORS ON THE SURGEON SIDE CONSOLE THAT THE SURGEON MANIPULATES TO GENERATE MOTION COMMANDS FOR THE UNIVERSAL SURGICAL MANIPULATORS (USM). ONE MTM IS ASSIGNED TO THE SURGEON'S RIGHT HAND (MTMR) AND ONE MTM IS ASSIGNED TO THE SURGEON'S LEFT HAND (MTML). AFTER TROUBLESHOOTING WITH NO RESOLUTION, THE CUSTOMER ABORTED TO ANOTHER DAVINCI SYSTEM. WHILE ON-SITE, THE FSE CONFIRMED THE REPORTED ERROR AND REPLACED THE RAC, GCC, AND GPD. IT WAS NOTED THAT FA WAS ABLE TO REPLICATE THE REPORTED 2551 ERROR ON THE RETURNED RAC. A SYSTEM LOG REVIEW WAS CONDUCTED, WHICH RESULTED IN THE FOLLOWING FINDINGS: IT WAS CONFIRMED THE CUSTOMER EXPERIENCED MULTIPLE 25551 ERRORS ON THE LEFT AND RIGHT MTMS DURING START-UP. A REVIEW OF THE SITE'S COMPLAINT HISTORY DOES NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS PRODUCT AND/OR THIS EVENT. THIS COMPLAINT IS BEING REPORTED DUE TO A DAVINCI SYSTEM MALFUNCTION RENDERING THE DAVINCI SYSTEM UNAVAILABLE FOR USE AFTER THE START OF A SURGICAL PROCEDURE. ALTHOUGH NO PATIENT HARM OCCURRED, IF THE REPORTED MALFUNCTION WERE TO RECUR, IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER RECEIVED AN ERROR STATING TO DISABLE THE LEFT AND RIGHT ARMS. THE TECHNICAL SERVICE ENGINEER (TSE) REVIEWED THE ERROR LOGS AND FOUND ERROR 2551 FOR THE LEFT AND RIGHT MASTER TOOL MANIPULATOR (MTM). THE TSE THEN HAD THE CUSTOMER POWER DOWN THE SYSTEM AND CYCLE THE SURGEON SIDE CONSOLE (SSC) BREAKER SEVERAL TIMES WITH NO CHANGE. THE TSE HAD THE CUSTOMER MOVE THE SSC AWAY FROM THE WALL AND CHECK FOR OBSTRUCTIONS TO THE MTMS. NO CABLES OR OTHER OBSTRUCTIONS WERE NOTED. THE CUSTOMER INFORMED THE TSE THAT THE MTMS WERE ALL THE WAY UP AND DID NOT MOVE WHEN STARTING UP THE SYSTEM. THE TSE HAD THE CUSTOMER POWER DOWN THE SYSTEM, MOVE THE MTMS ALL THE WAY DOWN, AND START THE SYSTEM, BUT THE ISSUE PERSISTED. IT WAS NOTED THE SYSTEM WAS HAVING ERRORS POINTING TO THE MTMS IN SUBSEQUENT START-UPS FOLLOWING THE INITIAL INSTANCE OF THE ERROR. THE CUSTOMER DECIDED TO ABORT THE PROCEDURE AND REQUESTED A FIELD SERVICE ENGINEER (FSE) CHECK THE SYSTEM. THERE WAS NO REPORTED INJURY OR HARM TO THE PATIENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE NURSE CONFIRMED THAT PRIOR TO PORT PLACEMENT, SHE TURNED ON THE SYSTEM AND NOTICED AN ERROR. THE NURSE NOTED THAT SHE CLEARED THE ERROR AND WAS ABLE TO CONTINUE WITH THE SETUP, AND NOTICED THE SYSTEM DEPLOYED FOR DRAPING, BUT NOT FOR DOCKING. IT WAS STATED THAT PORTS HAD BEEN PLACED AND ANESTHESIA HAD BEEN ADMINISTERED AT THE TIME OF THE ISSUE. THE NURSE REPORTED THAT THEY HAD TO WAKE THE PATIENT. NO VIDEO/IMAGE WAS AVAILABLE FOR REVIEW. THERE WAS NO REPORTED INJURY OR HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726634 DAVINCI XI SURGEON SIDE CONSOLE, SMART PEDALS NAY INTUITIVE SURGICAL, INC 380677-17 N/A 00886874110744

    Patients

    Seq Age Sex Outcome Treatment
    1