BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 24239839 · Received February 2, 2026

    Report

    Report Number
    2955842-2026-02645
    Event Type
    Injury
    Date Received
    February 2, 2026
    Date of Event
    January 4, 2026
    Report Date
    February 20, 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. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE ADVERSE EVENT DESCRIBED IS NOT RELATED TO A DA VINCI DEVICE, NOT RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO THE JURA SYSTEM: "THIS PATIENT DEVELOPED AN ILEUS 31 DAYS AFTER THE PROCEDURE. THIS IS A REMOTE EVENT AND UNLIKELY RELATED TO THE INDEX PROCEDURE, OR ANY DEVICE A MONTH EARLIER. BECAUSE OF THIS LATE TIME COURSE, MANY OTHER PATIENT OR ENVIRONMENTAL FACTORS WELL AFTER SURGERY COULD HAVE CONTRIBUTED TO THIS ILEUS. THERE IS NO EVIDENCE OF ANY RELATIONSHIP TO ANY DEVICE OR THE PROCEDURE AT THIS LATE COURSE." ADDITIONAL PATIENT INFORMATION: HEIGHT 189 CM., BODY MASS INDEX (BMI) 36.1KG/M2.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H2, H11. ADDITIONAL INFORMATION: TWELVE DAYS AFTER READMISSION, A LAPAROTOMY WITH ADHESIOLYSIS OF ADHERENT TERMINAL ILEUM TO THE RECTAL STUMP OCCURRED, WHICH WAS CAUSING AN OBSTRUCTIVE POINT. AN ABSCESS AT THIS SITE WAS DRAINED. TWO GENTAMICIN-IMPREGNATED SPONGES WERE PLACED, AND A PELVIC DRAIN WAS LEFT IN PLACE. CORRECTED INFORMATION: A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) AND IT WAS CONCLUDED THAT THE ADVERSE EVENTS DESCRIBED ARE NOT UNIQUE TO AN INTUITIVE PRODUCT AND THE INTUITIVE PRODUCT COULD NOT HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENTS: "THE PATIENT IN THIS REPORT HAD SEVERAL COMPLICATIONS INCLUDING A LIVER ABSCESS, A PERIRECTAL ABSCESS, AND A BOWEL MOTILITY ISSUE WHICH WAS INITIALLY THOUGHT TO BE AN ILEUS. THE PATIENT EVENTUALLY REQUIRED SURGERY AND LYSIS OF ADHESIONS (LOA) WHICH SUGGESTS THE BOWEL ISSUE THOUGHT TO BE AN ILEUS PROGRESSED TO AN OBSTRUCTION. ALTHOUGH THE PATIENT WAS READMITTED ON [DATE REDACTED] WHICH IS 31 DAYS AFTER THE INITIAL SURGERY, THE ONSET OF SYMPTOMS MAY HAVE DEVELOPED OVER TIME AND INTO THE STUDY PERIOD. THE ONSET AND TIMING OF SYMPTOMS WHICH LED TO THE READMISSION ARE NOT PROVIDED. THE LIVER ABSCESS OCCURRED WITHIN THE STUDY PERIOD [DATE REDACTED]. ALTHOUGH THE RECTAL AREA ABSCESS OCCURRENCE WAS DOCUMENTED OUTSIDE THE STUDY PERIOD [DATE REDACTED], IT WAS WITHIN A RELATIVELY SHORT TIME FROM THE PRIOR INTRABDOMINAL ABSCESS AND MAY HAVE BEEN A CONTINUATION OF THE SAME INFECTIOUS PROBLEM. THERE IS NO EVIDENCE ANY OF THESE COMPLICATIONS ARE RELATED TO THE JURA SYSTEM. THERE IS NO EVIDENCE THESE COMPLICATIONS WERE RELATED TO THE JURA PROCEDURE. THERE IS NO EVIDENCE THESE COMPLICATIONS WERE DUE TO THE DA VINCI SYSTEM. HOWEVER, THESE COMPLICATIONS (ABSCESSES, ILEUS, AND BOWEL OBSTRUCTION) ARE POTENTIAL ISSUES AFTER A LOW ANTERIOR RESECTION REGARDLESS OF MODALITY (LAPAROSCOPIC, ROBOTIC, OR OPEN) AND THEREFORE POSSIBLY RELATED TO THE DA VINCI PROCEDURE." ANNEX F NEW CODE: F19.

    Description of Event or Problem · 0

    A PATIENT IN A STUDY UNDERWENT A DA VINCI ASSISTED LOW ANTERIOR RESECTION WITH LIVER METASTASIS RESECTION SURGICAL PROCEDURE. TWENTY-SIX DAYS AFTER DISCHARGE, AN ILEUS OF THE SMALL INTESTINE WAS DISCOVERED REQUIRING REHOSPITALIZATION. A NASOGASTRIC (NG) TUBE WAS PLACED AS TREATMENT. THE NG TUBE HAS BEEN REMOVED; THE PATIENT IS NOW EATING SMALL PORTIONS OF FOOD AGAIN. SYMPTOMS OF NAUSEA AND VOMITING REMAIN. FOLLOWING THE INDEX PROCEDURE, THERE WERE NO REPORTED POST-OPERATIVE COMPLICATIONS OR RE-INTERVENTIONS; DISCHARGE OCCURRED FIVE DAYS LATER. THE PRIMARY INVESTIGATOR DETERMINED THERE IS NO RELATIONSHIP BETWEEN THE ILEUS AND THE STUDY PROCEDURE, THE PATIENT'S DISEASE, THE JURA SYSTEM, A DA VINCI DEVICE, OR A THIRD-PARTY DEVICE. THERE WAS NO REPORT OF A DA VINCI OR JURA DEVICE MALFUNCTION OR ANY ALLEGATION THAT A DA VINCI DEVICE OR JURA DEVICE CAUSED OR CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302285 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-39 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES.