BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 24664002 · Received March 23, 2026

    Report

    Report Number
    2955842-2026-16596
    Event Type
    Injury
    Date Received
    March 23, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 23, 2026
    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
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. ADDITIONAL PATIENT INFORMATION: HEIGHT 179 CM., BODY MASS INDEX (BMI) 24.0 KG/M2. A REVIEW OF THE EVENT INFORMATION PROVIDED WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO). THE MSO CONCLUDED THAT THE ADVERSE EVENT DESCRIBED IS NOT RELATED TO A DA VINCI PRODUCT BUT POSSIBLY RELATED TO THE PROCEDURE. FURTHERMORE, THE MSO STATED: "THE PATIENT IN THIS REPORT HAD A SEROSAL INJURY TO THE BOWEL WHICH WAS REPAIRED AT THE TIME OF THE INDEX OPERATION. NO ADDITIONAL COMPLICATIONS WERE REPORTED AS PART OF THIS INJURY. THE PATIENT¿S MULTIPLE PRIOR OPERATIONS LIKELY CONTRIBUTED TO THIS EVENT. THEREFORE, IT IS POSSIBLY RELATED TO THE PROCEDURE ALTHOUGH MORE LIKELY RELATED TO THE PATIENT¿S DISEASE. THERE IS NO EVIDENCE THE JURA SYSTEM, JURA PROCEDURE, OR THE DA VINCI DEVICE CONTRIBUTED TO THIS EVENT."

    Description of Event or Problem · 0

    A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED AND JURA SYSTEM LOW ANTERIOR RESECTION PROCEDURE. THE SURGICAL PROCEDURE WAS REPORTEDLY COMPLEX DUE TO PREVIOUS ABDOMINAL SURGERY WITH ADHESIONS AND STOMA PLACEMENT. ADHESIOLYSIS WAS REQUIRED TO OBTAIN ADEQUATE VISUALIZATION. DURING DISSECTION, AN UNINTENDED SMALL BOWEL SEROSAL INJURY OCCURRED. THE INJURY WAS IMMEDIATELY RECOGNIZED AND REPAIRED WITH SUTURES. THE EVENT WAS RESOLVED INTRAOPERATIVELY ON THE SAME DAY. THE PROCEDURE WAS COMPLETED USING THE DA VINCI SURGICAL SYSTEM WITHOUT ANY DEVICE MALFUNCTION. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MILD SEVERITY, NOT A SERIOUS ADVERSE EVENT, A OLSO CLASSIFICATION GRADE I, NOT RELATED TO THE STUDY PROCEDURE, NOT RELATED TO THE JURA SYSTEM, NOT RELATED TO THE DA VINCI SYSTEM, NOT RELATED TO A THIRD-PARTY DEVICE, BUT PROBABLY RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS. THE PATIENT'S PRIOR HEALTH CONDITION (PRIOR SURGERY AND STOMA PLACEMENT) MAY BE RELEVANT TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346394 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-39 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.