BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI XI

    MDR report key: 25131265 · Received May 8, 2026

    Report

    Report Number
    2955842-2026-24571
    Event Type
    Death
    Date Received
    May 8, 2026
    Date of Event
    May 14, 2025
    Report Date
    April 16, 2026
    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
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THERE WERE NO DA VINCI DEVICE ISSUES. NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC EVENT INFORMATION, OR ANY DA VINCI SYSTEM IDENTIFIERS. THE ARTICLE REPORTED TWO DEATHS AND OTHER POSTOPERATIVE COMPLICATIONS. SEE H10 FOR RELATED MANUFACTURER REPORT NUMBERS. A REVIEW OF THE EVENT PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE RESEARCH ARTICLE DESCRIBED A SERIES OF PATIENTS WHO UNDERWENT ROBOTIC PROSTATECTOMY. ONE PATIENT DIED OF A PULMONARY EMBOLISM. NO ALLEGATIONS HAVE BEEN MADE AGAINST ANY INTUITIVE SURGICAL PRODUCTS OR INSTRUMENTS. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, NO INTUITIVE SURGICAL PRODUCT OR INSTRUMENT CONTRIBUTED TO THIS EVENT. CITATION: YILMAZ, A.B., KARIMZADA, K., OZERCAN, A.Y. ET AL. COMPARISON OF DIFFERENT SCORING SYSTEMS FOR PREDICTION OF POSTOPERATIVE COMPLICATIONS AFTER ROBOT-ASSISTED RADICAL PROSTATECTOMY. J ROBOTIC SURG 19, 272 (2025). HTTPS://DOI.ORG/10.1007/S11701-025-02406-1. SECTION A2: PATIENT AGE: REFLECTS THE STUDY MEAN AGE OF 65YRS. THE AGE RANGE WAS 48-77 YRS. SECTION B7: MEDICAL HISTORY REFLECTS THE STUDY POPULATION CO-MORBIDITIES, NOT THE HISTORY OF THE SPECIFIC PATIENT. SECTION D: GENERIC DA VINCI XI SYSTEM PRODUCT INFORMATION IS PROVIDED AS THE SERIAL NUMBER WAS NOT PROVIDED. SECTION E - THE EVENT SITE RECORDED IS BASED ON THE LOCATION OF THE CORRESPONDING AUTHOR'S ASSOCIATED HOSPITALS ((B)(6)). SECTION E: THE CORRESPONDING AUTHOR IS DESIGNATED AS THE INITIAL REPORTER OF THE EVENT.

    Description of Event or Problem · 0

    REVIEW OF AN ARTICLE THAT COMPARED DIFFERENT SCORING SYSTEMS FOR PREDICTION OF POSTOPERATIVE COMPLICATIONS AFTER ROBOT ASSISTED RADICAL PROSTATECTOMY (RARP) WAS PERFORMED. THE RETROSPECTIVE STUDY ANALYZED 374 PATIENTS AT TWO DIFFERENT CENTERS UNDERGOING RAPR USING THE DA VINCI XI SYSTEM BETWEEN JANUARY 2019 AND JUNE 2024. THE SCORING SYSTEMS EVALUATED WERE ESTIMATION OF PHYSIOLOGIC ABILITY AND SURGICAL STRESS (EPASS), COMORBIDITY SCORE FOR ROBOTIC SURGERY (CRS), AND THE CHARLSON COMORBIDITY INDEX (CCI). ONE PATIENT IN THE RETROSPECTIVE REVIEW DEVELOPED A MASSIVE PULMONARY EMBOLISM RESULTING IN DEATH. NO SPECIFIC DETAILS OF THE EVENT WERE PROVIDED. THE CORRESPONDING AUTHOR RESPONDED TO A REQUEST FOR ADDITIONAL INFORMATION STATING THAT THE COMPLICATION WAS NOT RELATED TO THE DA VINCI SYSTEM, AND THAT THIS IS THE ONLY INFORMATION WE ARE ABLE TO PROVIDE DUE TO PATIENT CONFIDENTIALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613837 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Death DA VINCI INSTRUMENTS AND ACCESSORIES