BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 17015591 · Received May 27, 2023

    Report

    Report Number
    2955842-2023-14725
    Event Type
    Death
    Date Received
    May 27, 2023
    Date of Event
    December 15, 2021
    Report Date
    May 3, 2023
    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
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION GATHERED, THERE IS NO INDICATION OR REPORT THAT AN INTUITIVE SURGICAL INC. (ISI) DEVICE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT. NO PRODUCTS ARE EXPECTED TO BE RETURNED FOR EVALUATION. A REVIEW OF THE SYSTEM LOGS FOR BOTH THE ION AND THE DA VINCI SYSTEMS SHOWED NO RELATED ERRORS OCCURRING, DURING THE DIAGNOSTIC OR SURGICAL PROCEDURES, THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT. REVIEW OF THE EVENT, PERFORMED BY AN ISI ION MEDICAL SAFETY OFFICER (MSO) CONCLUDED, THAT AN 81-YEAR-OLD FEMALE UNDERWENT AN ION ENDOLUMINAL DYE MARKING PROCEDURE, FOLLOWED BY DA VINCI ASSISTED LUNG RESECTION OF A RIGHT UPPER LOBE LESION ON (B)(6) 2021. THERE WERE NO INTRA-OPERATIVE COMPLICATIONS. THERE WAS NO MALFUNCTION OF THE ION OR DA VINCE SYSTEM, INSTRUMENTS OR ACCESSORIES. REVIEW OF THE ION AND DA VINCI LOGS REVEALED NO RELATED SYSTEM ERRORS. POST OPERATIVE ACIDOSIS WAS NOTED 2-3 DAYS AFTER SURGERY. THE PATIENT WAS DISCHARGED ON (B)(6) 2021 WITHOUT FURTHER INCIDENT. THE PATIENT DIED ABOUT 4 MONTHS LATER ON (B)(6) 2022. THE DEATH WAS ATTRIBUTED TO A FAILURE TO THRIVE IN THE SETTING OF SIGNIFICANT CO MORBIDITIES INCLUDING COPD, PULMONARY HYPERTENSION, CEREBROVASCULAR DISEASE, AND ACTIVE TOBACCO USE FOR 57 YEARS. BASED ON THE AVAILABLE DATA, THE DEATH WAS DUE; TO A FAILURE TO THRIVE IN THE CONTEXT OF MULTIPLE CO MORBIDITIES. AND NEITHER DEVICE NOR PROCEDURE RELATED. REVIEW OF THE EVENT, PERFORMED BY AN ISI DA VINCI MEDICAL SAFETY OFFICER (MSO) CONCLUDED, THAT ACCORDING TO THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS. THIS PATIENT¿S DEATH OCCURRED 4 MONTHS AFTER THE PROCEDURE. THIS PATIENT HAD MANY COMORBIDITIES, WHICH MAY HAVE PLAYED A SIGNIFICANT ROLE. HOWEVER, NO EVIDENCE SUGGESTS AN ASSOCIATION WITH THE INITIAL PROCEDURE NOR WITH ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTATION. NO INTUITIVE SURGICAL INSTRUMENTATION OR PRODUCT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE PATIENT WAS INCLUDED IN A RETROSPECTIVE ION DYE MARKING STUDY. THAT INCLUDES MULTICENTER CHART REVIEW OF PATIENTS WHO UNDERWENT A PLEURAL BASED TISSUE DYE MARKING, WITH THE ION ENDOLUMINAL SYSTEM IN ANTICIPATION OF LUNG RESECTION. THE PATIENT UNDERWENT THE ION ENDOLUMINAL PROCEDURE. FOLLOWED BY A DA VINCI-ASSISTED WEDGE LUNG RESECTION ON (B)(6) 2021. APPROXIMATELY 4 MONTHS LATER, THE PATIENT PASSED AWAY ON (B)(6) 2022. THE CAUSE OF DEATH WAS STATED, TO BE FAILURE TO THRIVE. THE PATIENT HAD A PAST HISTORY OF CEREBROVASCULAR DISEASE, DYSPNEA, PULMONARY HYPERTENSION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), WEAKNESS AND WAS A CURRENT SMOKER FOR 57 YEARS. DURING PRE-OPERATIVE ASSESSMENT, A LESION WAS DISCOVERED IN THE RIGHT UPPER LOBE. THE PATIENT LATER UNDERWENT GENERAL ANESTHESIA AND THE ION DIAGNOSTIC PROCEDURE WAS COMPLETED. INCLUDING DYE MARKING WITH 0.2ML INDOCYANINE GREEN (ICG). THE ION BIOPSY PROCEDURE WAS COMPLETED WITH NO ISSUES. THE DA VINCI ASSISTED-WEDGE RESECTION WAS THEN COMPLETED ROBOTICALLY WITH NO INTRA-OPERATIVE COMPLICATIONS REPORTED. POST-OPERATIVELY THE PATIENT EXPERIENCED UNSPECIFIED ACIDOSIS AND SEDATION, AND WAS HOSPITALIZED APPROXIMATELY 2-3 DAYS, RELATED TO THE LUNG RESECTION. THE PATIENT WAS DISCHARGED ON (B)(6) 2021 WITH NO POST-OPERATIVE COMPLICATIONS NOTED. NO INFORMATION WAS AVAILABLE FOR THE TIME PERIOD BETWEEN PATIENT DISCHARGE AND EXPIRATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915508 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES