BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 24312633 · Received February 11, 2026

    Report

    Report Number
    2955842-2026-03581
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    January 6, 2026
    Report Date
    February 11, 2026
    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
    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. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) AND CONCLUDED THAT "AN ANASTOMOTIC LEAK FOLLOWING A LOW ANTERIOR RESECTION (LAR) IS A WELL-KNOWN COMPLICATION AND IS THEREFORE POSSIBLY RELATED TO THE SURGICAL PROCEDURE OF SIMPLY PERFORMING AN LAR. IT SHOULD BE NOTED THAT PATIENT RELATED VARIABLES OR COMORBIDITIES SUCH AS HISTORY OF PRIOR RADIATION AS NOTED FOR THIS PATIENT, MAY SIGNIFICANTLY CONTRIBUTE TO THE LIKELIHOOD OF THIS COMPLICATION. THERE IS NO EVIDENCE THE JURA WOULD CONTRIBUTE TO THIS COMPLICATION. THERE IS NO EVIDENCE PROVIDED THE DA VINCI CONTRIBUTED TO THIS COMPLICATION." ADDITIONAL PATIENT INFORMATION: HEIGHT 180 CM., BODY MASS INDEX (BMI) 27.2 KG/M2.

    Description of Event or Problem · 0

    A PATIENT ENROLLED IN A STUDY UNDERWENT A DA VINCI ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE. DISCHARGE OCCURRED NINE DAYS LATER. SIX DAYS AFTER DISCHARGE, THE PATIENT RETURNED TO THE EMERGENCY ROOM WITH COMPLAINTS OF ANAL PAIN WHICH STARTED TWO DAYS AFTER DISCHARGE. A COMPUTED TOMOGRAPHY (CT) SCAN OF THE ABDOMEN SUGGESTED A POSSIBLE ANASTOMOTIC LEAK. ONE DAY AFTER READMISSION, A RECTOSCOPY WAS PERFORMED CONFIRMING THE LEAKAGE. THE NEXT DAY, A RE-OPERATION OCCURRED DURING WHICH A PERMANENT COLOSTOMY WITH A STOMA WAS CREATED, AT WHICH TIME THE EVENT WAS REPORTED AS RESOLVED WITH SEQUELAE. DISCHARGE OCCURRED ONE WEEK AFTER RE-ADMISSION. THE STUDY INVESTIGATOR REPORTED THE EVENT AS SEVERE, A SERIOUS ADVERSE EVENT (REQUIRING MEDICAL OR SURGICAL INTERVENTION), CLAVIEN-DINDO GRADE IIIB, NOT RELATED TO THE STUDY PROCEDURE, NO RELATED TO THE JURA SYSTEM, NOT RELATED TO THE DA VINCI SYSTEM, BUT POSSIBLY RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS. THE PATIENT'S PRIOR HEALTH CONDITION OR MEDICATIONS THAT MAY BE RELEVANT TO THIS EVENT: THE PATIENT HAD CHEMORADIATION AND THE ANASTOMOSIS WAS LOCATED VERY DISTALLY. ESPECIALLY THE RADIATION MAKES IT MORE PRONE FOR ANASTOMOTIC LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377467 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-32 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| R| L DA VINCI INSTRUMENTS AND ACCESSORIES