BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 24336013 · Received February 13, 2026

    Report

    Report Number
    2955842-2026-04241
    Event Type
    Injury
    Date Received
    February 13, 2026
    Date of Event
    December 29, 2025
    Report Date
    February 13, 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
    GM
    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 170 CM.; BODY MASS INDEX (BMI) 21.1 KG/M2. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO). PER THE MSO: "THIS PATIENT HAD A MINOR BOWEL SEROSAL INJURY WHICH OCCURRED DURING DISSECTION IN A DENSELY ADHERENT AREA. WHILE THE TYPE OF PROCEDURE LIKELY HAS A CORRELATION TO THIS INJURY, THE PRIOR MYOMECTOMY AND SUBSEQUENT DENSE ADHESIONS ADDED A LEVEL OF COMPLEXITY TO THE PROCEDURE AND POSSIBLY CONTRIBUTED TO THE COMPLICATION. THEREFORE, THIS COMPLICATION WAS NOT RELATED TO THE STUDY DEVICE. THIS COMPLICATION WAS PROBABLY RELATED TO THE STUDY PROCEDURE AND POSSIBLY RELATED TO THE PATIENT¿S UNDERLYING ANATOMY/DISEASE."

    Description of Event or Problem · 0

    A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED BENIGN HYSTERECTOMY WITH SACROCOLPOPEXY, ADHESIOLYSIS AND RECTAL SUTURING SURGICAL PROCEDURE. INTRA-OPERATIVELY THE PATIENT EXPERIENCED A COMPLICATION. MASSIVE ADHESIONS WERE VISIBLE BETWEEN THE COLON AND THE POSTERIOR UTERINE WALL, WHICH WERE LIKELY DUE TO A PREVIOUS MYOMECTOMY. THESE ADHESIONS WERE INITIALLY RELEASED. DURING THE PROCESS, A SMALL SEROSAL DEFECT ON THE RECTUM WAS OBSERVED. THE DEFECT WAS CLOSED WITH A POLYDIOXANONE (PDS) SUTURE. THE EVENT WAS DEEMED RESOLVED AT THAT TIME. THE PROCEDURE WAS COMPLETED WITH NO MALFUNCTION OF THE DA VINCI SYSTEM, INSTRUMENTS OR ACCESSORIES. THERE WERE NO POST-OPERATIVE COMPLICATIONS, RE-OPERATIONS, OR PROLONGED HOSPITALIZATION. DISCHARGE OCCURRED TWO DAYS AFTER THE SURGICAL PROCEDURE. FOLLOWING DISCHARGE, THE PATIENT WAS NOT RE-ADMITTED TO HOSPITAL. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MILD SEVERITY, NOT A SERIOUS ADVERSE EVENT, AN OLSO CLASSIFICATION GRADE I, HAVING A CAUSAL RELATIONSHIP TO THE STUDY PROCEDURE, BUT NOT RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS, NOT RELATE THE DA VINIC INVESTIGATIONAL DEVICE, AND NOT RELATED TO A THIRD-PARTY DEVICE. THE PATIENT'S PRIOR HEALTH CONDITION (PERITONEAL ADHESIONS) MAY BE RELEVANT TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312787 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-43 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES