BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI X

    MDR report key: 14167752 · Received April 21, 2022

    Report

    Report Number
    2955842-2022-11171
    Event Type
    Death
    Date Received
    April 21, 2022
    Date of Event
    March 26, 2022
    Report Date
    March 28, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874115404
    PMA / PMN Number
    K171294
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S BLOOD LOSS LEADING TO DEATH IS UNKNOWN. HOWEVER, THE SURGEON ATTRIBUTED THE CAUSE OF THE BLEEDING TO THE ATTEMPTED RELEASE OF THE POSTERIOR ADHESIONS OF THE LIVER. ALTHOUGH THERE WAS A NON-RECOVERABLE ERROR AT THE BEGINNING OF THE PROCEDURE CAUSING THE DISABLING OF ARM 4, THE SURGEON STATED THAT THE SYSTEM MALFUNCTION DID NOT HAVE AN IMPACT ON THE PROCEDURE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. THE LOGS WERE REVIEWED BY AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND THE FOLLOWING FINDINGS WERE OBTAINED: THERE WERE NO PROCEDURES PERFORMED WITH THE SYSTEM SINCE THE REPORTED ISSUE. ERROR 23072 OCCURRED ON ARMNET 4 PRIOR TO START OF PROCEDURE AND THE SITE DISABLED UNIVERSAL SURGICAL MANIPULATOR (USM) 4 PRIOR TO THE START OF THE PROCEDURE. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE SYSTEM LOG REVIEW VERIFIED THAT AN ERROR 23072 OCCURRED. THE REPORTED ISSUE WAS REPLICATED AS ARM 4 FAILED WITH THREE RESTARTS. THE AXES CONTROLLER SETUP JOINT (ACJ) WAS REPLACED TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, FAILURE ANALYSIS OF THE PRODUCT RELATED TO THE COMPLAINT CANNOT BE PERFORMED. AN IMAGE SENT BY THE CUSTOMER WAS REVIEWED BY ISI CLINICAL DEVELOPMENT ENGINEERING (CDE) AND THE FOLLOWING INFORMATION WAS RECEIVED: THE IMAGE SHOWS EXCISED LIVER TISSUE. A MEDICAL REVIEW OF THE EVENT WAS CONDUCTED BY AN ISI MEDICAL OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: THE PATIENT UNDERWENT AN ATTEMPTED DA VINCI-ASSISTED HEPATECTOMY; HOWEVER, DUE TO SIGNIFICANT ¿ANTERIOR AND POSTERIOR¿ ADHESIONS THE PROCEDURE WAS NOT ABLE TO BE COMPLETED ROBOTICALLY. ACCORDING TO THE INFORMATION FROM THE DESCRIPTION OF EVENTS THERE WERE TWO SIGNIFICANT ISSUES THAT LED TO THE CONVERSION OF THE PROCEDURE FROM ROBOTIC TO OPEN, WHICH ARE AS FOLLOWS: INABILITY TO RELEASE THE POSTERIOR LIVER ADHESIONS AND THE LIVER TUMOR INFILTRATION INTO THE DIAPHRAGM AND INTESTINES. FROM THE DESCRIPTION OF EVENTS, IT SEEMS AS IF THE BLEEDING OCCURRED AFTER THE PROCEDURE WAS CONVERTED TO OPEN, MOST LIKELY DUE TO THE LOCAL TUMOR INVASION. THE ACUTE BLOOD LOSS ANEMIA RESULTED FROM THE ATTEMPTED RELEASE OF THE POSTERIOR ADHESIONS AND TUMOR REMOVAL. BASED UPON THE INFORMATION, THE PATIENT¿S ACUTE BLOOD LOSS ANEMIA LEADING TO THE DEATH RESULTED FROM THE ATTEMPTED RESECTION OF A LOCAL INFILTRATING LIVER TUMOR WAS DUE TO THE UNDERLYING PATHOLOGY. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED HEPATECTOMY PROCEDURE IN A PATIENT WITH A LIVER TUMOR, THE PATIENT HAD A LOT OF ADHESIONS SEEN ANTERIORLY AND POSTERIORLY. HAND-ASSISTED ADHESIOLYSIS WAS CARRIED OUT VIA A GEL PORT. AN INTRA-OPERATIVE ULTRASOUND SHOWED THAT THE TUMOR HAD GROWN EXTENSIVELY AND INVADED THE STRUCTURES POSTERIOR TO THE LIVER. THERE WERE ALSO A LOT OF ADHESIONS POSTERIOR OF THE LIVER TO THE DIAPHRAGM AND INTESTINES AS WELL. THE PROCEDURE WAS CONVERTED TO OPEN AND THE ADHESIOLYSIS OF THE POSTERIOR ASPECT OF THE TUMOR CAUSED EXCESSIVE BLEEDING. DURING THE PROCEDURE, 8 PACKS OF BLOOD AND 3 PACKS OF PLASMA WERE TRANSFUSED INTO THE PATIENT. THE BLOOD LOSS LED TO RESPIRATORY ARREST DURING THE PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE ICU POST PROCEDURE AND PASSED AWAY ON POD #1 DUE TO INTRAVASCULAR COAGULATION SECONDARY TO HYPOVOLEMIC ARREST. THERE IS NO ALLEGATION OF DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTION DURING THE PROCEDURE AND NO ALLEGATION THAT THE DA VINCI SYSTEM CONTRIBUTED TO THE PATIENT'S DEATH.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION INFORMATION CAN BE FOUND IN SECTIONS: H6 AND H10. ON 27-APR-2022, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM FAILURE ANALYSIS: THE CFG/ACJ UNIT WAS RETURNED FOR FAILURE ANALYSIS, BUT THE REPORTED FAILURE COULD NOT BE REPLICATED/CONFIRMED. THE AXES CONTROLLER SETUP JOINT (ACJ) PRINTED CIRCUIT ASSEMBLY (PCA) BOARD WAS INSTALLED ONTO A TEST SYSTEM AND RECALIBRATED WITHOUT ANY PROBLEM. THE BOARD RAN THROUGH 10 POWER CYCLES AND SAT IDLE FOR ONE HOUR, BUT THE ERROR WAS NOT REPLICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DA VINCI-ASSISTED HEPATECTOMY PROCEDURE, THE PATIENT HAD A LOT OF ADHESIONS SEEN ANTERIORLY AND POSTERIORLY. THE ANTERIOR PART OF THE TUMOR WAS REACHED BUT AN ULTRASOUND OF THE LIVER DONE INTRA-OPERATIVELY SHOWED THAT THE LIVER LESION WAS MUCH LARGER THAN WAS REPORTED ON THE CT SCAN PREVIOUSLY. THE PATIENT HAD A 6 CM HEPATIC TUMOR ON SEGMENT VI SEEN ON CT SCAN LESS THAN A MONTH AGO. AS THE POSTERIOR PART OF THE TUMOR WAS UNREACHABLE, THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO OPEN. THE TUMOR WAS FOUND TO HAVE OCCUPIED ALMOST HALF OF THE LIVER ORGAN. DURING THE PROCEDURE, 8 PACKS OF BLOOD AND 3 PACKS OF PLASMA WERE TRANSFUSED INTO THE PATIENT. THE PATIENT PASSED AWAY DURING EARLY HOURS IN THE INTENSIVE CARE UNIT (ICU) ON POST-OPERATIVE DAY (POD) #1. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE SURGEON AND OBTAINED THE FOLLOWING INFORMATION: PRIOR TO DOCKING THE PATIENT SIDE CART (PSC), ARM 4 FAILED WITH ERROR 23072. WHEN THE ERROR OCCURRED, THE PATIENT WAS ALREADY UNDER ANESTHESIA AND INCISION PORTS HAD BEEN PLACED. THE SYSTEM WAS RE-STARTED ON HARD CYCLE MODE, BUT THE ERROR PERSISTED. ARM 4 WAS THEN DISABLED. ACCORDING TO THE SURGEON, THE DISABLING OF THE ARM DID NOT HAVE AN IMPACT ON THE PROCEDURE OR AFFECT THE ACCESSIBILITY OF THE POSTERIOR ASPECT OF THE LIVER. A GEL PORT SYSTEM WAS INSERTED IN THE PATIENT AND THE BEDSIDE SURGEON CARRIED OUT HAND-ASSISTED REMOVAL OF THE ADHESIONS FROM THE ANTERIOR ASPECT OF THE LIVER TO FREE THE ORGAN. THE GEL PORT WAS PLANNED FROM THE BEGINNING AS THERE WAS NO LAPAROSCOPIC ULTRASOUND AVAILABLE. SO, THE SITE HAD TO USE AN INTRA-OPERATIVE PROBE INSTEAD THAT IS NORMALLY USED FOR OPEN SURGERY. THE SURGEON ATTEMPTED TO RELEASE THE POSTERIOR PART OF THE ORGAN AND OPEN A WINDOW FOR THE VIEW AND WORKSPACE FOR ROBOTIC INSTRUMENTS VIA THE HAND INSERTION PART BUT WAS UNABLE TO ACCESS THE POSTERIOR ASPECT OF THE LIVER DUE TO ADHESIONS AND THE TUMOR INFILTRATING THE UNDERLYING STRUCTURES (INTESTINES AND DIAPHRAGM). THE SURGEON CONVERTED THE PROCEDURE FROM A HAND-ASSIST PROCEDURE TO AN OPEN PROCEDURE AROUND 5 MINUTES AFTER THE HAND-ASSIST INSERTION. THERE WAS BLEEDING THAT OCCURRED AFTER THE HAND-ASSISTED PART WAS PERFORMED. THE AMOUNT OF BLEEDING INTRA-OPERATIVELY WAS 4L. THE CAUSE OF THE BLEEDING WAS DUE TO THE ATTEMPTED RELEASE OF THE POSTERIOR ADHESIONS OF THE LIVER. THE BLOOD LOSS CAUSED RESPIRATORY ARREST AND HEMODYNAMIC CHANGES WITH OXYGEN SATURATION DROP AS WELL AS A CHANGE IN THE CARDIAC FREQUENCY IN THE PATIENT. FOLLOWING THE PROCEDURE, THE PATIENT HAD A HYPOVOLEMIC ARREST DUE TO THE BLOOD LOSS IN THE OPERATING ROOM. THE CAUSE OF DEATH PROVIDED BY THE SURGEON WAS INTRAVASCULAR COAGULATION SECONDARY TO HYPOVOLEMIC ARREST. THE SURGEON INDICATED THERE WAS NO MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. THERE ARE NO INSTRUMENTS AVAILABLE TO RETURN TO ISI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770783 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-40 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male DA VINCI INSTRUMENTS AND ACCESSORIES