BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 25331865 · Received May 29, 2026

    Report

    Report Number
    2955842-2026-26837
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 29, 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
    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 169 CM., BODY MASS INDEX (BMI) 45.2 KG/M2.

    Description of Event or Problem · 0

    A PATIENT IN A STUDY UNDERWENT A DA VINCI ASSISTED BENIGN HYSTERECTOMY WITH PLANNED CONCOMITANT BILATERAL SALPINGECTOMY AND FIBROMA REMOVAL ON MONS PUBIS SURGICAL PROCEDURE. DURING VAGINAL CUFF CLOSURE THE PATIENT EXPERIENCED AN INTRA-OPERATIVE BLEEDING, AN ESTIMATED BLOOD LOSS OF 400 ML. THE BLEEDING ORIGINATED FROM THE LEFT PARAVAGINAL REGION. AT THE TIME THE BLEEDING OCCURRED REPOSITIONING WAS PERFORMED FOR VAGINAL INSPECTION AND MANAGEMENT OF A SMALL VAGINAL TEAR ON THE RIGHT USING VICRYL EKN, AS WELL AS A VAGINAL TEAR AT THE VAGINAL VAULT WITH A CONTINUOUS SUTURE. THE CAUSE OF THE BLEEDING WAS DIFFICULT VAGINAL REMOVAL OF THE LARGE UTERUS REQUIRING PARTIAL MORCELLATION. THE VAGINAL ATTEMPT TO VISUALIZE AND CONTROL THE BLEEDING WAS UNSUCCESSFUL; THEREFORE, THE DECISION WAS MADE TO PROCEED WITH A PFANNENSTIEL LAPAROTOMY. A VENOUS BLEEDING FROM THE PARAMETRIUM WAS IDENTIFIED, GRASPED WITH AN OVERHOLT CLAMP, AND LIGATED. SUCTION AND IRRIGATION WERE PERFORMED, AND RESORBA-CELL WAS PLACED ON THE LEFT PELVIC WALL. THE EVENT WAS THEN REPORTED AS RESOLVED. THE PATIENT RECEIVED A TRANSFUSION OF ONE PACK OF PACKED RED BLOOD CELLS (PRBC) THE DAY AFTER SURGERY AND ONE PACK OF PRBCS THE FOLLOWING DAY. THE EVENT RESULTED IN A PROLONGED HOSPITALIZATION. DISCHARGE TO HOME OCCURRED SIX DAYS AFTER THE SURGICAL PROCEDURE. THERE WAS NO REPORT OF A DA VINCI DEVICE MALFUNCTION DURING THE PROCEDURE. NO BLOOD LOSS OCCURRED DUE TO THE USE OF AN ISI PRODUCT. AN INTUITIVE PRODUCT, INSTRUMENT, OR SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED BLEEDING EVENT. THE STUDY INVESTIGATOR REPORTED THE EVENT AS A MODERATE SEVERITY, NOT A SERIOUS ADVERSE EVENT, AND AN OLSO-CLASSIFICATION GRADE II, POSSIBLY RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS, BUT NOT RELATED TO THE STUDY PROCEDURE, NOT RELATED TO THE DA VINIC INVESTIGATIONAL DEVICE, AND NOT RELATED TO A THIRD-PARTY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143902 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-35 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1