BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 16078036 · Received December 30, 2022

    Report

    Report Number
    2955842-2022-16217
    Event Type
    Death
    Date Received
    December 30, 2022
    Report Date
    December 2, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSES OF THE TWO PATIENT DEATHS CANNOT BE DETERMINED. THERE IS NO ALLEGATION OR REPORT OF A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A SYSTEM LOG REVIEW CANNOT BE PERFORMED DUE TO INSUFFICIENT PROVIDED. THE EVENT DATES AND SPECIFIC DA VINCI SYSTEM INFORMATION ARE UNKNOWN. NO IMAGE OR VIDEO CLIPS FOR THE REPORTED EVENTS WERE SUBMITTED BY THE CUSTOMER FOR REVIEW. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: AFTER UNDERGOING DA VINCI-ASSISTED COMPONENT SEPARATION BY TAR PROCEDURES, TWO PATIENTS EXPIRED. THE ISSUE OCCURRED WITHIN 30 DAYS POSTOPERATIVELY. THE CAUSES OF THE POST-OPERATIVE DEATHS ARE UNKNOWN.

    Description of Event or Problem · 0

    ON (B)(6) 2022, INTUITIVE SURGICAL, INC. (ISI) BECAME AWARE OF A BRITISH JOURNAL OF SURGERY (BJS) OPEN ARTICLE TITLED, ¿OPEN VERSUS ROBOTIC-ASSISTED LAPAROSCOPIC POSTERIOR COMPONENT SEPARATION IN COMPLEX ABDOMINAL WALL REPAIR¿ (DEWULF, M., HIEKKARANTA, J.M., ET AL., 2022). STUDY DATA WAS COLLECTED BETWEEN DECEMBER 2011 AND OCTOBER 2019 AT MARIA MIDDELARES HOSPITAL, GHENT, BELGIUM (MMH); AND BETWEEN AUGUST 2017 AND MAY 2021 AT OULU UNIVERSITY HOSPITAL, OULU, FINLAND (OUH), WITH A TOTAL OF 169 PATIENTS (RTAR: N=90, OTAR: N=79). THE ARTICLE DESCRIBED A TWO-CENTRE CASE-CONTROL STUDY USING A PROSPECTIVELY DEVELOPED DATABASE (EUROPEAN REGISTRY FOR ABDOMINAL WALL HERNIAS (EURAHS)13) BASED ON ELECTRONIC CLINICAL FILES FROM PATIENTS UNDERGOING BILATERAL PCST (EITHER OPEN OR ROBOTIC-ASSISTED). THE PURPOSE OF THE STUDY WAS TO COMPARE OUTCOMES OF OPEN (OTAR) VERSUS ROBOTIC ASSISTED (RTAR) POSTERIOR COMPONENT SEPARATION BY TRANSVERSUS ABDOMINIS RELEASE (TAR). PATIENTS WERE OPERATED BY A SINGLE SURGEON IN MMH AND BY TWO SURGEONS AT OUH. THE ROBOTIC-ASSISTED SURGICAL PROCEDURES WERE PERFORMED WITH THE DA VINCI XI OR SI SYSTEMS. WITHIN THE JOURNAL ARTICLE, TWO DEATHS OCCURRED IN THE RTAR GROUP WITHIN 30 DAYS AFTER SURGERY. ATTEMPTS TO CONTACT THE AUTHORS FOR ADDITIONAL SPECIFIC INFORMATION REGARDING EVENTS PER SITE, THE DA VINCI SYSTEM USED PER EVENT, AND THE SPECIFIC PATIENT INFORMATION WERE UNSUCCESSFUL. IN ADDITION, THERE WERE EIGHT CONVERSIONS TO OPEN SURGERY IN THE RTAR GROUP DUE TO ADHESIONS (N=8), SEVERE BLEEDING (N=2), SMALL BOWEL INJURY (N=1), AND FULL-THICKNESS STOMACH INJURY (N=1). ALL PATIENTS HAD A FOLLOW-UP VISIT DURING THE FIRST 3 MONTHS AFTER SURGERY. AT MMH, A ROUTINE CLINICAL FOLLOW-UP VISIT 1 YEAR AFTER SURGERY WAS PERFORMED. DURING THESE FOLLOW-UP PERIODS, FIVE PATIENTS EXPERIENCED HERNIA RECURRENCE AND FOUR PATIENTS REQUIRED REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2409839 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-31 N/A

    Patients

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