BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 24470801 · Received February 27, 2026

    Report

    Report Number
    2955842-2026-14233
    Event Type
    Injury
    Date Received
    February 27, 2026
    Date of Event
    January 19, 2026
    Report Date
    March 13, 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

    ADDITIONAL INFORMATION: DISCHARGE OCCURRED 33 DAYS AFTER THE INDEX PROCEDURE.

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. THEREFORE, NO PRODUCTS ARE EXPECTED FOR RETURN TO INTUITIVE SURGICAL, INC. (ISI) FOR FAILURE ANALYSIS EVALUATION. ADDITIONAL PATIENT INFORMATION: HEIGHT 178 CM., BODY MASS INDEX (BMI) 22.7 KG/M2.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED AND JURA SYSTEM LOW ANTERIOR RESECTION PROCEDURE. FOUR DAYS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED AN ELEVATED C-REACTIVE PROTEIN AND A POST-OPERATIVE CT SCAN SHOWED A POSSIBLE ANASTOMOTIC LEAKAGE. A RECTOSCOPE PROCEDURE (UNDER SEDATION) SHOWED NO DEFECT AND ANTIBIOTHERAPY WAS STARTED. FOUR DAYS LATER, A CT SCAN SHOWED AN ACCEPTABLE STATE; ANTIBIOTICS WERE STOPPED TWO DAYS LATER. THREE DAYS LATER, AN ELEVATION OF C-REACTIVE PROTEIN WAS NOTED AND A CT SCAN SHOWED AN ANASTOMOTIC LEAKAGE WITH 2 ABSCESSES IN LOWER ABDOMEN. A RECTOSCOPE PROCEDURE (UNDER SEDATION) SHOWED A 20% DEHISCENCE OF A RECTUM LOW ANTERIOR RESECTION (LAR) ANASTOMOSIS FOR WHICH COLOVASCENT WAS ADMINISTERED. THREE DAYS LATER, A LAPAROSCOPIC DESCENDOCOLOSTOMY - DOUBLE BARRELED IN FRONT OF ANASTOMOTIC LEAKAGE WAS PERFORMED AND A DIVERTING STOMA WAS CREATED TO ALLOW HEALING OF THE RECTAL ANASTOMOSIS WITH APPLICATION OF A VAC SPONGE. ANTIBIOTICS WERE STOPPED AT THAT TIME; AN ENDOVACSTENT REMAINS. THE NEXT DAY, THE VAC SPONGE WAS REPLACED WITH A COLONIC STENT. SEVEN DAYS LATER, THE STENT WAS CHANGED BACK TO A VAC SPONGE. DURING THE REMAINDER OF THE ADMISSION, TWO ADDITIONAL VAC SPONGE CHANGES WERE PERFORMED, WITH WELL-GRANULATING TISSUE NOW VISIBLE. THE EVENT IS ONGOING. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MODERATE SEVERITY, A SERIOUS ADVERSE EVENT (REQUIRING MEDICAL OR SURGICAL INTERVENTION), CLAVIEN-DINDO GRADE IIIB, POSSIBLY RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS, POSSIBLY RELATED TO A THIRD-PARTY DEVICE (POSSIBLE - STAPLING DEVICE, CEA PURPLE, END-TO-END ANASTOMOSIS CIRCULAR STAPLER), BUT NOT RELATED TO THE STUDY PROCEDURE, NOT RELATED TO THE JURA SYSTEM AND NOT RELATED TO THE DA VINCI SYSTEM. THE PATIENT'S PRIOR HEALTH CONDITION (IRRADICAL ESD T2 RETUMCARCINOMA [DATE REDACTED], DIABETES TYPE 2, HYPERTENSION AND LOW ANASTOMOSIS) MAY BE RELEVANT TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36540 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-39 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention| H DA VINCI INSTRUMENTS AND ACCESSORIES.