BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 24248130 · Received February 3, 2026

    Report

    Report Number
    2955842-2026-03010
    Event Type
    Injury
    Date Received
    February 3, 2026
    Date of Event
    December 9, 2025
    Report Date
    April 2, 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
    FR
    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 163 CM., BODY MASS INDEX (BMI) 26.0 KG/M2.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: G3, G6, H2, AND H11. ADDITIONAL INFORMATION: DURING THE 30-DAY FOLLOW-UP VISIT, A LUNG INFECTION WAS SUSPECTED. A CT SCAN SHOWED A LOBAR LESION (REPORTED AS BRONCHIOLITIS), A 5-DAY COURSE OF ANTIBIOTIC THERAPY WAS PRESCRIBED. APPROXIMATELY THREE MONTHS LATER, A SECOND CT SCAN FOUND THE LOBAR LESION WAS STILL PRESENT AND A NEW 5-DAY COURSE OF ANTIBIOTIC (AUGMENTIN) WAS PRESCRIBED. APPROXIMATELY FOUR MONTHS AFTER THE SECOND CT SCAN, ANOTHER CT SCAN FOUND NO LOBAR LESION AND THE EVENT WAS DEEMED RESOLVED. IT WAS REPORTED THE PATIENT IS PRONE TO LUNG INFECTIONS, DUE TO A DIAGNOSIS OF COPD POST-SMOKING, AND IS CURRENTLY BEING FOLLOWED BY THE PNEUMOLOGY DEPARTMENT. THE SITE REPORTED THIS BRONCHIOLITIS IS RELATED TO THE COPD AND NOT TO THE SURGERY. THE STUDY INVESTIGATOR REPORTED THE EVENT OF BRONCHIOLITIS AS MODERATE SEVERITY, NOT A SERIOUS ADVERSE EVENT, A CLAVIEN-DINDO GRADE II, HAVING A CAUSAL RELATIONSHIP TO THE PATIENT'S UNDERLYING DISEASE STATUS (COPD), BUT NOT RELATED TO THE DA VINCI STUDY DEVICE, AND NOT RELATED TO THE STUDY PROCEDURE.

    Description of Event or Problem · 0

    A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED PULMONARY SEGMENTECTOMY. DURING THE DAY 30 FOLLOW-UP VISIT, A 5-DAY COURSE OF ANTIBIOTIC THERAPY WAS PRESCRIBED DUE TO A SUSPECTED LUNG INFECTION. IT WAS INDICATED THAT GIVEN THE PATIENT¿S COPD, THE ANTIBIOTIC THERAPY WAS PRESCRIBED PREVENTIVELY DUE TO SUSPICION OF A LUNG INFECTION AND WAS NOT CONSIDERED RELATED TO A COMPLICATION. THE INDEX PROCEDURE WAS COMPLETED WITH NO COMPLICATION, AND NO MALFUNCTION OF THE DA VINCI DEVICE, INSTRUMENTS OR ACCESSORIES. AS PER STANDARD CARE, A CHEST TUBE DRAIN WAS INSERTED AFTER SURGERY AND WAS REMOVED ON POST-OPERATIVE DAY SIX. DISCHARGE OCCURRED THE NEXT DAY. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278433 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-33 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES.