BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 18620189 · Received January 31, 2024

    Report

    Report Number
    2955842-2024-10963
    Event Type
    Death
    Date Received
    January 31, 2024
    Date of Event
    January 3, 2024
    Report Date
    January 3, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL FIELD SERVICE ENGINEER TESTED THE UNIVERSAL SURGICAL MANIPULATORS 1 AND 4 AND CONFIRMED THEY FUNCTIONED AS EXPECTED. USM 4 WAS REPLACED AT THE REQUEST OF THE CUSTOMER. THE INVESTIGATION OF THIS EVENT IS ON-GOING. UNIVERSAL SURGICAL MANIPULATOR WAS INVESTIGATED BY FAILURE ANALYSIS. THE FAILURE IS NOT CONFIRMED AND WAS NOT REPLICATED. A REVIEW OF THE EVENT BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE PATIENT HAD A NUMBER OF PREOPERATIVE COMORBIDITIES THAT WERE COMPOUNDED BY SEVERAL ISSUES THAT OCCURRED BOTH INTRAOPERATIVELY AND POSTOPERATIVELY. THE PLANNED SIGMOID COLECTOMY WAS EVENTUALLY COMPLETED; HOWEVER, POSTOPERATIVELY THE PATIENT CODED AND EXPIRED THAT SAME DAY. THE DETAILS THAT LED TO THE CODE AND THE CAUSE OF DEATH WERE NOT PROVIDED. BASED ON THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 0

    FUNCTIONAL INVESTIGATION OF THE UNIVERSAL SURGICAL MANIPULATORS (USM) 1 AND 4 WAS PERFORMED BY INTUITIVE SURGICAL FIELD SERVICE AT THE USER FACILITY BEFORE RETURN OF THE REPLACED USM 4 FOR ADDITIONAL EVALUATION. BOTH USM 1 AND 4 FUNCTIONED AS EXPECTED. UPON RECEIPT, USM 4 WAS ALSO INVESTIGATED BY INTUITIVE SURGICAL FAILURE ANALYSIS. THE REPORTED EVENT WAS NOT REPLICATED. A REVIEW OF THE SYSTEM LOGS FOR THIS PROCEDURE FOUND NO RELEVANT SYSTEM ERRORS. MULTIPLE PROCEDURES HAVE BEEN PERFORMED WITH THE DA VINCI SYSTEM SUBSEQUENT TO THE REPORTED EVENT WITH NO RELATED ERRORS. A REVIEW OF THE DA VINCI SYSTEM LOG KINEMATIC DATA WAS PERFORMED. BASED ON AN ESTIMATED TIME OF THE EVENT FROM THE SURGEON, THE KINEMATICS DATA SHOWED AN EVENT WHERE THE INSTRUMENT WAS NOT FULLY INSERTED INTO THE PREVIOUS POSITION BEFORE THE INSTRUMENT CLUTCH WAS ACTIVATED, WHICH DEACTIVATES THE GUIDED TOOL CHANGE (GTC) FUNCTION. THE REPORTED EVENT OF A SMALL BOWEL PERFORATION DURING INSTRUMENT EXCHANGE LIKELY OCCURRED WHEN THE GUIDED TOOL CHANGE (GTC) WASN'T FULLY COMPLETED AND THE INSTRUMENT CLUTCH WAS ENGAGED. THE MOST LIKELY CAUSE FOR THE REPORTED ISSUE IS RELATED TO AN INCOMPLETE GTC, AND A CLUTCH BUTTON BEING ACCIDENTALLY PRESSED. THE DA VINCI INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING INFORMATION REGARDING THE GUIDED TOOL CHANGE: IF GUIDED TOOL CHANGE IS ENABLED, THE LED ON THE INSTRUMENT CARRIAGE AND ON THE TOP OF THE ARM BLINKS GREEN. THE SYSTEM ALSO DISPLAYS A MESSAGE TO ADVANCE THE INSTRUMENT OR ENDOSCOPE TO RETURN TO THE PREVIOUS LOCATION. IF GUIDED TOOL CHANGE IS NOT ENABLED, THE LED DOES NOT BLINK GREEN. THE SYSTEM ALSO DISPLAYS AN ICON AND MESSAGE INSTRUCTING THE USER TO INSERT THE INSTRUMENT PAST THE CANNULA TIP AND ADVANCE. THESE ACTIONS DISABLE THE GUIDED TOOL CHANGE: PRESSING A PORT CLUTCH OR INSTRUMENT CLUTCH BUTTON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPIRED AFTER A DA VINCI-ASSISTED SIGMOID COLECTOMY PROCEDURE. INTRAOPERATIVE COMPLICATIONS INVOLVING A SMALL BOWEL INJURY, SPLENIC CAPSULE INJURY, AND BLEEDING OCCURRED AND THE PATIENT EXPIRED LATER THE SAME DAY. DURING A GUIDED TOOL CHANGE (GTC) FROM A VESSEL SEALER EXTEND (VSE) TO A MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT, A SMALL BOWEL PERFORATION OCCURRED. THE SURGEON STATED SHE WAS NOT WATCHING DURING THE MCS INSTRUMENT INTRODUCTION. AN ADDITIONAL BOWEL RESECTION WAS PERFORMED TO ADDRESS THE INJURY BEFORE CONTINUING WITH THE SIGMOID COLECTOMY. DURING SUBSEQUENT DISSECTION, THE SPLENIC CAPSULE WAS INJURED RESULTING IN A ONE HOUR PAUSE IN THE PROCEDURE UNTIL ANOTHER SURGEON WAS AVAILABLE TO PERFORM A SPLENECTOMY DUE TO AN ENLARGED SPLEEN AND CONTINUED BLEEDING. A SUREFORM 60 STAPLER WAS USED TO LIGATE THE SPLENIC VESSELS. THE SPLENECTOMY WAS COMPLETED ROBOTICALLY WITH NO REPORTED COMPLICATIONS. THE SIGMOID COLECTOMY PROCEDURE WAS THEN COMPLETED AS PLANNED. THE ESTIMATED BLOOD LOSS WAS 1200 ML TREATED WITH TRANSFUSION OF BLOOD PRODUCTS AND TRANEXAMIC ACID. THE SURGEON STATED THAT THERE WAS NO SIGNIFICANT BLEEDING FROM THE SPLENECTOMY; THE PATIENT HAD CONTINUOUS OOZING AND THE BLOOD LOSS WAS FROM THE ENTIRE PROCEDURE AS A WHOLE. POSTOPERATIVELY THE PATIENT CODED; RESUSCITATION ACTIVITIES WERE PERFORMED, THE PATIENT WAS REVIVED AFTER A BLOOD TRANSFUSION; HOWEVER, EXPIRED LATER THE SAME DAY OF THE PROCEDURE. THE SURGEON BELIEVES THE BLOOD LOSS OCCURRED DUE TO THE PATIENT'S HIGH-RISK STATUS AND COMORBIDITIES THAT PUT TOO MUCH STRAIN ON THE PATIENT'S HEART, WHICH LED TO THE EXPIRATION. THE PATIENT WAS TRANSFUSED WITH PLATELETS BEFORE THE START OF THE PROCEDURE. THE PATIENT¿S MEDICAL HISTORY INCLUDED IMMUNE THROMBOCYTOPENIC PURPURA (ITP), CORONARY ARTERY BYPASS GRAFT, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CHRONIC LYMPHOMA, AND DIVERTICULAR BLEEDING WITH BLOOD TRANSFUSIONS.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392554 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male DA VINCI INSTRUMENTS AND ACCESSORIES.