BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 24424402 · Received February 23, 2026

    Report

    Report Number
    2955842-2026-05261
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    February 5, 2025
    Report Date
    April 21, 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
    NO
    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). PER THE MSO, THE POSTOPERATIVE AIR LEAK THAT WAS NOT DETECTED WHILE THE ORIGINAL CHEST DRAIN WAS IN PLACE AND WAS SUBSEQUENTLY IDENTIFIED LATER IS POSSIBLY RELATED TO THE PROCEDURE AND/OR THE PATIENT¿S UNDERLYING LUNG DISEASE. THE MSO NOTED THAT THE COMPLICATION WAS NOT RELATED TO THE STUDY DEVICE. ADDITIONAL PATIENT INFORMATION: HEIGHT 167 CM., BODY MASS INDEX (BMI) 24.0 KG/M2.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: G3, G6, H2, H6, AND H11 ADDITIONAL INFORMATION: THE SURGICAL INTERVENTION THAT WAS REPORTED HAS BEEN SPECIFIED AS CHEST TUBE PLACEMENT. CORRECTED DATA: ANNEX B FIELD CHANGED FROM B17 TO B15.

    Description of Event or Problem · 0

    A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE. TWO DAYS AFTER SURGERY AND PRIOR TO DISCHARGE, THE PATIENT EXPERIENCED A PNEUMOTHORAX AFTER CHEST TUBE REMOVAL AND SUBCUTANEOUS EMPHYSEMA WHICH REQUIRED SURGICAL INTERVENTION AND PROLONGED HOSPITALIZATION. THE INTERVENTION WAS NOT PERFORMED UNDER GENERAL ANESTHESIA AND THERE WAS NO ICU ADMISSION. THE EVENT WAS REPORTED AS RESOLVED SEVEN DAYS LATER; DISCHARGE OCCURRED THE SAME DAY. THE INDEX PROCEDURE WAS COMPLETED WITH NO INTRA-OPERATIVE COMPLICATIONS OR DA VINCI DEVICE DEFICIENCIES. NO RE-ADMISSIONS OR RE-INTERVENTIONS HAVE BEEN REPORTED SINCE DISCHARGE. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MILD SEVERITY, NOT A SERIOUS ADVERSE EVENT, A CLAVIEN-DINDO GRADE IIIA, NOT RELATED TO THE DA VINCI INVESTIGATIONAL DEVICE, POSSIBLY RELATED TO THE PROCEDURE, AND POSSIBLY RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS. THE PATIENT PRIOR HEALTH HISTORY OF SMOKING AND EMPHYSEMA MAY BE RELEVANT TO THIS INCIDENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229813 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| H DA VINCI INSTRUMENTS AND ACCESSORIES.