BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 12601931 · Received October 9, 2021

    Report

    Report Number
    2955842-2021-11266
    Event Type
    Death
    Date Received
    October 9, 2021
    Date of Event
    September 7, 2021
    Report Date
    September 15, 2021
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874110720
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE CURRENT INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED OR IS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. SITE HISTORY COMPLAINT REVIEW WAS CONDUCTED ON 27-SEP-2021 AND DID NOT SHOW ANY ADDITIONAL COMPLAINTS RELATED TO THIS EVENT. NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. SYSTEM ERROR LOG REVIEW WAS CONDUCTED ON 07-SEP-2021 ON SYSTEM SK3692. THERE WERE NO OBSERVED EVENTS IN THE SYSTEM LOGS THAT WOULD SUGGEST A PRODUCT ISSUE AND LOGGED EVENTS ARE IN LINE WITH NORMAL SYSTEM FUNCTIONALITY. A REVIEW OF THE INSTRUMENT LOGS WAS ALSO PERFORMED. WHILE NOT ALL REUSABLE INSTRUMENTS USED IN THE CASE HAVE BEEN USED IN SUBSEQUENT PROCEDURES AT THIS TIME, A SITE HISTORY SEARCH SHOWS NO COMPLAINTS FILED AGAINST THOSE INSTRUMENTS. AN ISI ADVANCED FAILURE ANALYST (AFA) ENGINEER CONDUCTED AN ADDITIONAL SYSTEM LOG REVIEW AND FOUND THE FOLLOWING: THERE WAS ONLY ONE ERROR IN THE LOGS FOR THAT PROCEDURE; A CLASS 0 (SYSTEM SERVICE ADVISORY (NO FAULT REACTION)) IESU ERROR FOR THE MAXIMUM ENERGY ACTIVATION TIME BEING EXCEEDED WHICH IS RESOLVED BY RELEASING THE ENERGY ACTIVATION PEDAL AND REACTIVATING IF NEEDED. NO PRODUCT ISSUES WERE FOUND. AN ISI MEDICAL SAFETY OFFICER (MSO) CONDUCTED MEDICAL REVIEW AND RESULTS WERE AS FOLLOWS: BASED UPON THE INFORMATION PROVIDED IN THE DESCRIPTION OF EVENTS, THERE IS INSUFFICIENT EVIDENCE TO DETERMINE IF THE DA VINCI SYSTEM, INSTRUMENT, AND/OR ACCESSORIES CAUSED OR CONTRIBUTED TO THIS EVENT. THE DESCRIBED EVENT MEETS THE CRITERIA OF A REPORTABLE ADVERSE EVENT. AT THIS TIME, THE SPECIFIC SURGICAL TASK BEING PERFORMED AND WHY IT WAS BEING PERFORMED AT THE TIME OF THE EVENT, THE SPECIFIC INSTRUMENT THAT WAS USED FOR THE SURGICAL TASK, AND THE ROOT CAUSE OF THE VESSEL INJURY LEADING TO A CONVERSION TO OPEN SURGERY DUE TO A BLEEDING EVENT AND THE PATIENT'S SUBSEQUENT DEATH ARE UNKNOWN.

    Description of Event or Problem · 1

    ON 23-SEP-2021, AN INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES ASSOCIATE (CSA), VIA AN INITIAL REPORT FROM THE SURGEON, CONTACTED AN ISI REGULATORY GROUP BY EMAIL TO INITIALLY REPORT THAT AFTER A DA VINCI-ASSISTED LOBECTOMY PROCEDURE ON (B)(6) 2021, THE PATIENT PASSED AWAY. THE CSA SAID THAT THE INITIAL PROCEDURE HAD CONVERTED FROM DA VINCI TO OPEN DUE TO BLEEDING IN THE CHEST AND THAT HE WAS NOTIFIED A WEEK LATER THAT THE PATIENT DID PASS AWAY. ON (B)(6) 2021, ISI OBTAINED THE FOLLOWING ADDITIONAL INFORMATION FROM THE CONSOLE SURGEON REGARDING THE REPORTED EVENT: THE SURGEON STATED THAT THIS WAS AN UNFORTUNATE SITUATION; THAT HE HAS DONE OVER A THOUSAND NON-ROBOTIC LOBECTOMY PROCEDURES IN HIS CAREER AND HAS NEVER LOST ANYONE. THE SURGEON SAID THAT HE HAD A PROCTOR RIGHT NEXT TO HIM AS THIS WAS HIS FIRST ROBOTIC CASE. THE FOLLOWING WAS CONFIRMED BY THE CONSOLE SURGEON: DURING DA VINCI-ASSISTED LOBECTOMY (RIGHT UPPER LOBE) PROCEDURE THAT WAS PERFORMED ON (B)(6) 2021 ON AN ELDERLY FEMALE PATIENT, A BLEEDING EVENT OCCURRED AND THE PROCEDURE CONVERTED TO OPEN SURGERY. THE SURGEON HAD OPENED UP THE TOP AND HAD TOTAL CONTROL. THE SURGEON SAID THAT HE HAD EVERYTHING ALREADY SEPARATED AND IT WAS ALL DONE. THE PROCTOR ALLEGEDLY SAID SMOOTH SAILING; ITS DOWNHILL FROM HERE. THE SURGEON WENT TO MOVE THE APICAL TRUCK OFF THE PA [PULMONARY ARTERY] AROUND THE BACKSIDE, AND THE SURGEON SAID HE, SAW RED. THE SURGEON OBSERVED BLEEDING FROM THE PA. THE SURGEON SAID THAT HE HAD JUST TAKEN A BIPOLAR BOVIE AND WAS GOING TO ATTEMPT TO WIPE THE BACK WALL, BUT THEN,  THE PA TORE AT THE TAKE-OFF FROM THE MAIN TRUNCUS WHEN THE SURGEON WENT TO LIFT UP ON THE PARENCHYMAL LOBE. THE SURGEON SAID THAT THE MAIN PA WAS FUSED AND THAT HE COULD FEEL SCAR TISSUE AND THAT IT DIDNT GIVE AT ALL. THE SURGEON SAID, I DONT KNOW IF I HAD TOO MUCH TENSION ON THE APICAL TRUNK OR NOT BUT THAT THE PA WAS FUSED FROM SCAR TISSUE. THE SURGEON SAID THAT EVEN THOUGH HE HAD ARTERIALLY AND MEDIALLY DISSECTED IT THAT PERHAPS HE DIDNT APPRECIATE THE TENSION SO WHEN THE SURGEON WENT TO LIFT UP ON THE PARENCHYMAL LOBE, BLEEDING FROM THE PA RESULTED. THE SURGEON WAS ABLE TO PRESSURE PACK THE PA TO CONTROL BLEEDING. THE PROCEDURE CONVERTED TO OPEN SURGERY AT THIS POINT AND THE BLEEDING WAS STILL STOPPED FROM THE PRESSURE PACK. WHEN THE SURGEON TOOK OFF THE PRESSURE PACK DURING THE OPEN SURGERY, THE PA BLED YET THE SPECIFIC AMOUNT WAS NOT DISCLOSED. THE VESSEL WAS SUTURE REPAIRED. THE PATIENT WAS RESUSCITATED AMONG OTHER THINGS AND THE OPEN SURGERY COMPLETED. THE PATIENT WENT TO THE INTENSIVE CARE UNIT (ICU) (B)(6) 2021. THE PATIENT EXPIRED ON (B)(6) 2021 AFTER THE FAMILY WITHDREW CARE. THE SURGEON ATTRIBUTED THE CAUSE OF THE PATIENTS DEATH TO EXSANGUINATION AND HYPOVOLEMIA DUE TO ACUTE BLOOD LOSS FROM PULMONARY ARTERY BLEEDING WHICH WAS EXACERBATED BY THE FOLLOWING PATIENT ANATOMY ISSUES AND PATIENT HISTORY: LOTS OF SCAR TISSUE, THE RIGHT PA WAS PLASTERED IN THE BACK, THE PATIENT HAD A PREVIOUS EMERGENCY CORONARY ARTERY BYPASS GRAFT SURGERY (CABG) ONE YEAR PRIOR TO THIS EVENT AND AN ADDITIONAL HISTORY OF CORONARY ARTERY DISEASE (CAD), SEIZURES, AND OTHER PATIENT HISTORY. THE SURGEON SAID THAT THERE WERE NO ISSUES WITH A DA VINCI PRODUCT. THE SURGEON SAID THIS WAS AN UNFORTUNATE EVENT THAT HAD NOTHING TO DO WITH DA VINCI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499751 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-48 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1