BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 17981774 · Received October 21, 2023

    Report

    Report Number
    2955842-2023-19486
    Event Type
    Death
    Date Received
    October 21, 2023
    Date of Event
    September 19, 2023
    Report Date
    September 21, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROBOTICS COORDINATOR INITIALLY CONTACTED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEERING (TSE) TO REPORT THAT THE UNIVERSAL SURGICAL MANIPULATOR ARM 1 WAS DRIFTING; IT OCCURRED OUTSIDE OF THE PATIENT AFTER REMOVING A STAPLER FROM THE ARM. IT WAS BELIEVED THAT THERE MAY HAVE BEEN AN ISSUE WITH THE GUIDED TOOL CHANGE. THE ROBOTICS COORDINATOR CONFIRMED THAT SUBSEQUENT CASES PERFORMED OVER THE NEXT COUPLE DAYS DID NOT HAVE ANY ARM DRIFTING REPORTED. TSE REVIEWED THE LOGS AND FOUND NO RELATED ISSUES. AN ISI FIELD SERVICE ENGINEER EVALUATED THE SYSTEM AT THE HOSPITAL SITE. ALL 4 ROBOT ARMS WERE TESTED AND DRIFTING COULD NOT BE REPLICATED ON ARM 1, OR ANY OF THE OTHER ARMS. THE FSE EXPLAINED THE GUIDED TOOL CHANGE PROCESS AND THE IMPORTANCE OF THE SURGEON TAKING THEIR HEAD OUT OF THE VIEWER WHEN THEIR HANDS ARE NOT IN THE MASTER TOOL MANIPULATORS. IN A SUBSEQUENT CONTACT BETWEEN TSE AND THE ROBOTICS COORDINATOR IT WAS EXPLAINED THAT THE ¿DRIFT¿ DURING GUIDED TOOL CHANGE LIKELY IS DUE TO THE TIP OF THE NEW INSTRUMENT MOVING OVER TO THE LOCATION WHERE THE TIP OF THE REMOVED INSTRUMENT WAS AS DESIGNED. DURING SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER, THE ROBOTICS COORDINATOR REPORTED THAT THE PATIENT HAD EXPIRED. AN ADVANCED SYSTEM LOG REVIEW SHOWED THAT THERE WERE NO RELEVANT ERROR MESSAGES RELATED TO THE REPORTED EVENT. ADDITIONALLY, REVIEW OF THE 5 SUBSEQUENT PROCEDURES PERFORMED WITH THE SYSTEM AFTER THE REPORTED EVENT SHOWED THAT NO SYSTEM ERRORS WERE CAPTURED. THE INSTRUMENTS NOTED BELOW WERE USED DURING THE REPORTED PROCEDURE. REVIEW OF THE INSTRUMENT LOGS FOUND THAT THE FOLLOWING MULTIPLE USE DEVICES WERE USED IN SUBSEQUENT PROCEDURES AFTER THE EVENT DATE WITH NO REPORTED COMPLAINTS AND HAVE REMAINING LIVES: TWO ENDOSCOPE PLUS 30 DEGREE CAMERAS, MARYLAND BIPOLAR FORCEPS, TIP-UP FENESTRATED GRASPER, FENESTRATED BIPOLAR FORCEPS AND CADIERE FORCEPS. THE MULTIPLE USE FENESTRATED BIPOLAR FORCEPS AND ENDOWRIST STAPLER 30 CURVED-TIP HAVE LIVES REMAINING BUT HAVE NOT BEEN USED IN SUBSEQUENT PROCEDURES. THE SUREFORM 45 AND SUREFORM 60 STAPLERS, AND THE SUCTION IRRIGATOR ARE SINGLE-USE INSTRUMENTS AND THEREFORE HAVE NOT BEEN USED IN SUBSEQUENT PROCEDURES. A DEVICE HISTORY RECORD REVIEW FOR THE DEVICE(S) USED DURING THE PROCEDURE SHOWED NO NON-CONFORMANCES WERE IDENTIFIED THAT WERE RELATED TO THIS EVENT. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT BASED ON THE AVAILABLE INFORMATION, THE PATIENT IN THIS REPORT HAD A CATASTROPHIC BLEED FROM AN INJURY TO THE PULMONARY ARTERY DURING A PULMONARY LOBECTOMY. HOW THAT INJURY OCCURRED AND THE INSTRUMENTATION IN USE WHEN THE INJURY OCCURRED WAS NOT PROVIDED. BASED ON THE INFORMATION IN THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION IS AVAILABLE TO ASCERTAIN IF ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI ASSISTED PULMONARY LOBECTOMY, THE PROCEDURE WAS CONVERTED TO OPEN SURGERY TO ADDRESS BLEEDING FROM THE PULMONARY ARTERY. THE ROBOTICS COORDINATOR STATED THAT WHILE NOT PRESENT AT THE PROCEDURE, THE OR STAFF PROVIDED INFORMATION THAT THE CONVERSION WAS DUE TO PATIENT ANATOMY. MORE SPECIFICALLY, IT WAS STATED THAT THERE WAS BLEEDING, AND THE SURGEON WAS UNABLE TO VISUALIZE THE BRANCHES OF THE PULMONARY ARTERY WITH THE SYSTEM. ALTHOUGH BOTH THE ORIGINATION POINT OF WHERE THE BLEEDING STARTED FROM, AND THE AMOUNT OF BLOOD LOSS WERE UNKNOWN, IT WAS STATED THAT THE EVENT WAS ATTRIBUTED TO A HOLE IN THE PULMONARY ARTERY. THE PATIENT EXPIRED 7 MINUTES OUT FROM THE OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983404 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES