BEUDAMED
    FDA Adverse Event Death Summary report: N

    DAVINCI X

    MDR report key: 22883473 · Received August 25, 2025

    Report

    Report Number
    2955842-2025-35521
    Event Type
    Death
    Date Received
    August 25, 2025
    Date of Event
    May 23, 2024
    Report Date
    July 31, 2025
    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
    CI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. A REQUEST FOR ADDITIONAL EVENT INFORMATION WAS SUBMITTED TO THE CORRESPONDING AUTHOR. THE RESPONSE RECEIVED PROVIDED AN EXPLANATION THAT COLLECTING THE INFORMATION REQUIRES TIME AND RESOURCES, AND THE INFORMATION IS COVERED BY STRICT CONFIDENTIAL AND ETHICAL REGULATIONS; THEREFORE, NO INFORMATION WILL BE PROVIDED. A REVIEW OF THE EVENT WAS CONDUCTED BY AN ISI MEDICAL OFFICER AND CONCLUDED THAT ONE PATIENT IN THIS SINGLE HOSPITAL LITERATURE REVIEW OF 186 PATIENTS DIED AS A RESULT OF COMPLICATIONS FROM AN INTRAOPERATIVE BLEEDING EVENT DURING A CARDIAC PROCEDURE. THE SPECIFIC PROCEDURE AND HOW THIS INJURY MAY HAVE OCCURRED WERE NOT PROVIDED. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, INSUFFICIENT INFORMATION IS PROVIDED TO DETERMINE IF ANY INTUITIVE SURGICAL PRODUCT OR INSTRUMENT CONTRIBUTED TO THIS EVENT. CITATION: HUGUET, F., ACUNA, B., LOPEZ, M., ET AL. 2024. TOWARDS THE FUTURE OF SURGERY: DESCRIPTIVE ANALYSIS OF THE IMPLEMENTATION OF THE FIRST ROBOTIC SURGERY CENTER IN A NATIONAL PUBLIC HOSPITAL. REV CIR. 2025; 77(1). DOI: HTTP://DX.DOI.ORG/10.35687/S2452-454920250012339. SECTION B3 - THERE IS INSUFFICIENT INFORMATION REGARDING THE PROCEDURE DATE; THEREFORE, THE ARTICLE PUBLISH DATE WAS USED. SECTION E1 - THIS ARTICLE WAS IDENTIFIED DURING A LITERATURE REVIEW BY INTUITIVE; THE CORRESPONDING AUTHOR IS DESIGNATED AS THE REPORTER.

    Description of Event or Problem · 0

    A RETROSPECTIVE STUDY WAS SUMMARIZED IN A LITERATURE ARTICLE. THE STUDY ANALYZED 186 PATIENTS UNDERGOING ROBOTIC SURGERIES ACROSS 7 SURGICAL SPECIALTIES IN THE FIRST ROBOTIC SURGERY CENTER IN A NATIONAL PUBLIC HOSPITAL BETWEEN OCTOBER 2022 AND OCTOBER 2023. THE STUDY'S INTENT WAS TO IDENTIFY THE PATIENT POPULATIONS, EVALUATE THE COSTS OF THE SURGERIES AND REPORT THE SURGICAL OUTCOMES. ONE PATIENT UNDERWENT AN UNSPECIFIED CARDIAC SURGERY AND EXPERIENCED AN INTRA-OPERATIVE HEMORRHAGE DUE TO AN UNSPECIFIED VASCULAR INJURY WHICH REQUIRED CONVERSION TO OPEN; THEN IN THE IMMEDIATE POST-OPERATIVE PERIOD DEVELOPED DISSEMINATED INTRAVASCULAR COAGULATION (DIC) RESULTING IN DEATH. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT ATTRIBUTE ANY EVENTS TO ANY DA VINCI DEVICES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292187 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-41 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| D DA VINCI INSTRUMENTS AND ACCESSORIES.