BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 23826964 · Received December 17, 2025

    Report

    Report Number
    2955842-2025-48767
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    February 20, 2025
    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
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: H2, H6, AND H11. ADDITIONAL INFORMATION AND CORRECTED DATA: THE PATIENT HAD A NUCLEUS PROLAPSE IN THE BACK WITH SYMPTOMS STARTING 16 DAYS AFTER THE PROCEDURE. AN MRI CONFIRMED THIS DIAGNOSIS. A MEDICAL REVIEW OF THE EVENT INFORMATION WAS PROVIDED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER AND CONCLUDED THAT VERTEBRAL DISC PROLAPSE IS UNRELATED TO THE STUDY DEVICE OR INVESTIGATIONAL PROCEDURE AND IS LIKELY PRE-EXISTING/CHRONIC. THE ADVERSE EVENT IS NOT RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE INVESTIGATIONAL PROCEDURE.

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORT THAT A DA VINCI SYSTEM, INSTRUMENT OR ACCESSORY MALFUNCTIONED DURING THE PROCEDURE. ADDITIONAL PATIENT INFORMATION: HEIGHT - 167 CM., BODY MASS INDEX (BMI) - 24.0 KG/M2. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THE EXPIRATION DATE FOR SECTION D4 IS NOT APPLICABLE. SECTION D6 IS BLANK BECAUSE THE PRODUCT IS NOT IMPLANTABLE. INFORMATION FOR THE BLANK FIELDS IN SECTION E1 IS NOT AVAILABLE. SECTIONS G5 AND G7 ARE NOT APPLICABLE. SECTION H10 IS BLANK AS THERE ARE NO RELATED REPORT NUMBERS.

    Additional Manufacturer Narrative · 0

    THE EVENT WAS REPORTED AS AN UNCOMPLICATED NUCLEUS PROLAPSE L5/S1, SPONTANEOUSLY RESOLVED. TREATMENT INCLUDED OBSERVATION AND MEDICATION (ANALGESICS). THE DATE OF RESOLUTION WAS EIGHT DAYS AFTER THE EVENT WAS REPORTED. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MILD, A CLAVIEN-DINDO GRADE I, NOT RELATED TO A DA VINCI DEVICE, NOT RELATED TO THE PROCEDURE, AND NOT RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS.

    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 PULMONARY LEFT INFERIOR LOBECTOMY PROCEDURE ON (B)(6) 2025. SEVENTEEN DAYS AFTER THE INDEX PROCEDURE, AN UNSPECIFIED PROLAPSE WAS REPORTED. DETAILS OF THE PROLAPSE AND ANY MEDICAL TREATMENTS, REQUIRED INTERVENTIONS OR OUTCOME WERE NOT REPORTED. THE INDEX PROCEDURE WAS COMPLETED AND THE PATIENT WAS DISCHARGED HOME NINE DAYS LATER. THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION OR ANY ALLEGATION THAT A DA VINCI DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE STUDY INVESTIGATOR REPORTED THE EVENT AS NON-SERIOUS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316058 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 DA VINCI INSTRUMENTS AND ACCESSORIES