BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI XI

    MDR report key: 17813770 · Received September 25, 2023

    Report

    Report Number
    2955842-2023-18713
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    August 29, 2023
    Report Date
    August 29, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PROXIMAL SET UP JOINT AND COMPLETED THE FAILURE ANALYSIS. THE PROXIMAL SUJ WAS INSTALLED ON THE TEST PLATFORM AND IT FAILED NODE CHECK. THE ERROR WAS CONFIRMED VIA SYSTEM LOGS REVIEW AND REPLICATED ON THE IN-HOUSE TEST SYSTEM. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) DID RECEIVE THE DA VINCI PRODUCTS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE UNIVERSAL POWER DISTRIBUTOR (UPD) WAS INSTALLED AND TESTED ON THE PCA TEST SYSTEM. THE SYSTEM STARTED UP WITHOUT ANY ERROR, WITH GOOD IMAGE. THE AUDIO WAS LOUD AND CLEAR. ALL OTHER TESTS PASSED. THE UPD REMAINED ON THE TEST SYSTEM FOR HOURS IN NORMAL OPERATION WITH NO ISSUE. THE REPORTED FAILURE COULD NOT BE REPLICATED. THE UNIVERSAL SURGICAL MANIPULATOR(USM) WAS ANALYZED AND THE REPORTED ISSUE COULD NOT BE REPLICATED DURING IN-HOUSE TESTING. WHEN ARM WAS TESTED FROM AN IN-HOUSE SYSTEM, IT PASSED NORMAL MODE. DURING PFTP TEST, THE USM PASSED ALL PFTP REQUIRED TESTS. LOGS RECORDED A 1007 ERROR. THE UNIT WAS POWER CYCLED 25 TIMES AND NO ERRORS COULD BE REPLICATED. THE DISTAL SET UP JOINT (SUJ) UNIT WAS PLACED ON THE PFTP WITH A GOLDEN SFL INSTALLED AND THE UNIT PASSED ALL TESTS. THE PROXIMAL SUJ WAS RECEIVED AND FAILURE ANALYSIS HAS NOT BEEN COMPLETED YET.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. CUSTOMER CONTACTED NEXT DAY SAYING THE ERROR RETURNED. FSE REPLACED PROXIMAL SETUP JOINT (SUJ) AND UNIVERSAL POWER DISTRIBUTOR (UPD) AS SUSPECT COMPONENTS. DURING REPLACEMENT OF SUJ PROXIMAL, DAMAGE WAS CAUSED TO SUJ DISTAL POGO PINS WHICH RESULTED IN NOT BEING ABLE TO PROGRAM THE NEW SUJ PROXIMAL, SO SUJ DISTAL WAS ALSO REPLACED. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE THE DA VINCI PRODUCTS INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THE COMPLAINT WAS CONFIRMED BASED ON THE FIELD EVALUATION, WHICH INDICATES THAT THE DEVICE MAY HAVE CONTRIBUTED TO THE CUSTOMER REPORTED ISSUE.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED MALIGNANT HYSTERECTOMY PROCEDURE, THE SYSTEM SUDDENLY HAD A RECOVERABLE ERROR. THE CUSTOMER DISABLED ARM 1 AFTER WHICH A NON-RECOVERABLE ERROR SHOWED UP. A TECHNICAL SUPPORT ENGINEER (TSE) GUIDED THE CUSTOMER THROUGH POWER CYCLE INCLUDING HARD POWER CYCLE AN EMERGENCY POWER OFF (EPO) ON THE PATIENT SIDE CART (PSC). THIS SOLVED THE ISSUE AND AFTER DOCKING SURGERY CONTINUED. THE TSE REVIEWED THE LOGS AND FOUND ERRORS 32100, 1007 AND 307 POINTING TO ARM 1 UNIVERSAL SIDE MANIPULATOR (USM) AND/OR SET UP JOINT (SUJ) PROXIMAL. AFTER A FEW MOMENTS, THE SYSTEM ERROR RETURNED. THE CUSTOMER DISABLED ARM 1 AND INITIALLY STATED THEY CANNOT CONTINUE. TSE EXPLAINED THAT SYSTEM CAN BE USED SAFELY WITH 3 ARMS AND SURGEON AT THE END DECIDED TO CONTINUE WITH 3 ARMS BUT NEEDED TO MOVE ARM 1 OUT OF THE WAY. TSE ADVISED TO USE A BIT OF FORCE SINCE ARM WAS DISABLED BUT THE CUSTOMER STATED THEY WERE NOT ABLE TO MOVE AT ALL. SURGEON DECIDED TO POWER CYCLE SYSTEM, MOVE ARM 1 OUT OF THE WAY AND CONTINUE SURGERY WITH 3 ARMS. TSE ADVISED THE CUSTOMER TO DISABLE ARM 1 PRIOR TO CONTINUE WITH SURGERY BUT SURGEON ALREADY CONTINUED AND DECIDED THAT IF ERROR COMES BACK AGAIN, THEY WILL DISABLE THE ARM AT THAT TIME. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT HARM, ADVERSE OUTCOME OR INJURY WITH A DELAY OF THE PROCEDURE LESS THAN 15 MINUTES. INTUITIVE SURGICAL, INC. (ISI) OBTAINED THE FOLLOWING ADDITIONAL INFORMATION REGARDING THIS EVENT: THE SYSTEM WAS CHECKED UPON POWERING AND NO ERRORS OCCURRED. SYSTEM WAS RESTARTED TO ENABLE ARM 1 TO BE MOVED OUT OF THE WAY. PROCEDURE WAS COMPLETED WITH ARMS 2 AND 4 AND A MANUAL ASSISTANT PORT. THEY USED THE PORT WHICH WAS DOCKED TO ARM 1 AS A MANUAL ASSIST PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1810033 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-50 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 Female DA VINCI INSTRUMENTS AND ACCESSORIES