BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 24940444 · Received April 21, 2026

    Report

    Report Number
    2955842-2026-21938
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    December 14, 2024
    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. ADDITIONAL PATIENT INFORMATION: HEIGHT 168 CM., BODY MASS INDEX (BMI) 24.8 KG/M2. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) AND IT WAS CONCLUDED THAT THE ADVERSE EVENT DESCRIBED IS NOT UNIQUE TO AN INTUITIVE PRODUCT AND THE INTUITIVE PRODUCT COULD NOT HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT; HOWEVER, THE EVENT IS PROBABLY RELATED TO THE PROCEDURE. "REACTIVE PLEURAL EFFUSION IS PROBABLY RELATED TO THE POST-LOBECTOMY SPACE."

    Description of Event or Problem · 0

    A PATIENT IN A STUDY UNDERWENT A DA VINCI ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE. EIGHTEEN DAYS LATER, AFTER DISCHARGE, A PLEURAL EFFUSION WAS IDENTIFIED. THE EVENT REQUIRED RE-HOSPITALIZATION, UNSPECIFIED MEDICATION AND ULTRASOUND-GUIDED PLACEMENT OF A PIGTAIL CHEST TUBE (NOT UNDER GENERAL ANESTHESIA) AS TREATMENT. THE EVENT WAS THEN DEEMED RESOLVED TWO DAYS LATER. THE INDEX PROCEDURE WAS COMPLETED WITHOUT DOCUMENTED ADVERSE EVENTS OR DA VINCI DEVICE MALFUNCTIONS; DISCHARGE OCCURRED FOUR DAYS LATER. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MILD SEVERITY, A CLAVIEN-DINDO GRADE III, REQUIRING REHOSPITALIZATION, REQUIRING INTERVENTION (SURGICAL, ENDOSCOPIC OR RADIOLOGICAL) NOT UNDER GENERAL ANESTHESIA, NOT A SERIOUS ADVERSE EVENT, PROBABLY RELATED TO THE PROCEDURE, BUT NOT RELATED TO THE DA VINCI STUDY DEVICE, AND NOT RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593286 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-40 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES