BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SP

    MDR report key: 14325289 · Received May 7, 2022

    Report

    Report Number
    2955842-2022-11457
    Event Type
    Death
    Date Received
    May 7, 2022
    Report Date
    May 14, 2020
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE, THERE ARE NO PRODUCTS EXPECTED FOR RETURN TO ISI FOR EVALUATION. A MEDICAL REVIEW OF THE EVENT WAS CONDUCTED BY AN ISI MEDICAL OFFICER AND THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: "THE ARTICLE TITLED ¿ONE-YEAR OUTCOMES FOR DA VINCI SINGLE PORT ROBOT FOR TRANSORAL ROBOTIC SURGERY¿ (K. VAN ABEL, ET AL., 2019) RETROSPECTIVELY REVIEWED A COHORT OF 78 TORS CASES. THERE WERE TWO POST-OPERATIVE MORTALITIES NOTED. ONE DUE TO A POST-OPERATIVE PULMONARY EMBOLISM AND ONE DUE TO A POST-OPERATIVE BLEED. THIS MEDICAL REVIEW WILL FOCUS ON THE POST-OPERATIVE MORTALITY DUE TO PULMONARY EMBOLISM. THE AUTHORS OF THE ARTICLE REVIEWED ALL INTRA-OPERATIVE EVENTS DURING THE USE OF THE SP SYSTEM TO PERFORM THE TORS PROCEDURE. THE AUTHORS OF THE ARTICLE DID NOT IDENTIFY ANY INTRA-OPERATIVE COMPLICATIONS OR ANY SYSTEM OR INSTRUMENT RELATED ISSUES THAT MAY HAVE CONTRIBUTED TO THE PATIENT¿S POST-OPERATIVE PULMONARY EMBOLISM. ACCORDING TO THE ARTICLE ¿VENOUS THROMBOEMBOLISM RISK IN HEAD AND NECK CANCER: SIGNIFICANCE OF THE PREOPERATIVE PLATELET-TO-LYMPHOCYTE RATIO¿ OTOLARYNGOLOGY-HEAD AND NECK SURGERY, 06-FEB-2018, T THAM, L RAHMAN, C PERSAUD, ET. AL. THE REPORTED INCIDENCE RATE OF IN PATIENTS WITH HEAD AND NECK CANCER IS BETWEEN 1.4% TO 5.8% AND MAY EVEN BE UP TO 13% HIGHER WHEN COMPARED TO NON-CANCER PATIENTS. THE ASSOCIATION BETWEEN THROMBOEMBOLISM AND MALIGNANCY HAS BEEN RECOGNIZED FOR MORE THAN 150 YEARS, ORIGINALLY DESCRIBED BY ARMAND TROUSSEAU IN 1865. HEAD AND NECK SURGEONS CAN BE RELUCTANT TO USE ANTI-COAGULATION DUE TO THE RISKS RELATED TO BLEEDING. POST-OPERATIVE BLEEDING IN HEAD AND NECK SURGERY CAN RESULT IN POST-OPERATIVE HEMATOMA, AIR WAY COMPROMISE AND POSSIBLY DEATH. THE USE OF VTE CHEMOPROPHYLAXIS CAN RESULT IN A SIX-FOLD INCREASE IN POST-OPERATIVE BLEEDING AND HEMATOMA. THE RESULT OF THE POST-OPERATIVE PULMONARY EMBOLISM IS DUE TO THE FORMATION OF A DEEP VEIN THROMBOSIS DUE TO THE HYPERCOAGULABLE STATE THAT HAS BEEN CLEARLY DEMONSTRATED OVER THE PAST 150 YEARS IN PATIENTS WITH MALIGNANCY. THE RESULTING PULMONARY EMBOLISM AND SUBSEQUENT MORTALITY IS NOT RELATED TO THE USE OF THE SP SYSTEM AND INSTRUMENTATION. I AGREE WITH THE CONCLUSION OF THE AUTHORS OF ARTICLE TITLED ¿ONE-YEAR OUTCOMES FOR DA VINCI SINGLE PORT ROBOT FOR TRANSORAL ROBOTIC SURGERY¿ (K. VAN ABEL, ET AL., 2019)." A SYSTEM LOG REVIEW CANNOT BE PERFORMED SINCE NO PROCEDURE DATE WAS PROVIDED OR IS KNOWN. NO IMAGES OR VIDEOS WERE SUBMITTED FOR ISI¿S EVALUATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING A DA VINCI-ASSISTED PROCEDURE, THE PATIENT EXPERIENCED A POST-OPERATIVE PULMONARY EMBOLUS AND EXPIRED. AT THIS TIME, THE CAUSES OF THE POST-OPERATIVE PULMONARY EMBOLUS AND SUBSEQUENT PATIENT DEATH ARE UNKNOWN. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. REFER TO MEDWATCH REPORT (MDR) WITH PATIENT IDENTIFIER (B)(6) REGARDING THE PATIENT DEATH NOTED WITHIN THE JOURNAL ARTICLE ASSOCIATED WITH POST-TONSILLECTOMY HEMORRHAGING.

    Description of Event or Problem · 0

    ON 14-MAY-2020, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A HEAD & NECK ARTICLE TITLED, ¿ONE-YEAR OUTCOMES FOR DA VINCI SINGLE PORT ROBOT FOR TRANSORAL ROBOTIC SURGERY¿ (VAN ABEL, K. M., YIN, L. X., ET AL., 2020). WITHIN THE JOURNAL ARTICLE, AN OPERATIVE COMPLICATION INVOLVING A DA VINCI SURGICAL PROCEDURE WAS NOTED. WITHIN THE ARTICLE, THE FOLLOWING IS NOTED: ¿THERE WERE 4 POSTOPERATIVE HEMORRHAGES FOR AN OVERALL BLEED RATE OF 5.1%. THE DETAILS ON THESE POSTOPERATIVE HEMORRHAGE EVENTS ARE REPORTED IN TABLE 3. THERE WERE TWO MORTALITIES IN THIS COHORT OF 78, ONE SECONDARY TO A POST-TONSILLECTOMY HEMORRHAGE AND ANOTHER SECONDARY TO A POSTOPERATIVE PULMONARY EMBOLUS, FOR AN OVERALL MORTALITY RATE OF 2.6%¿ PROCEDURE INFORMATION PROCEDURE CATEGORY PROCEDURE NAME TRANSORAL ROBOTIC SURGERY. ISI FOLLOWED-UP WITH THE AUTHOR, WHO STATED THE FOLLOWING REGARDING THE REPORTED COMPLICATIONS: THERE WAS NO ALLEGATION OR CLAIM THAT A MALFUNCTION OF THE SYSTEM OR INSTRUMENT WAS INVOLVED IN THESE COMPLICATIONS. "THESE ARE KNOWN RISKS WITH THIS SURGICAL PROCEDURE, DOCUMENTED WITH THE SI AND TRANSORAL LASER MICROSURGERY AS WELL. WE DID NOT IDENTIFY A RATE HIGHER THAN THE PUBLISHED AVERAGES." NOTE: THIS COMPLAINT WAS CREATED TO LOG 1 OF 2 PATIENT DEATHS. THIS RECORD CAPTURES THE POST-OPERATIVE PULMONARY EMBOLISM AND SUBSEQUENT PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232725 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-33 N/A 00886874114605

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES