BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 25172475 · Received May 14, 2026

    Report

    Report Number
    2955842-2026-25006
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    March 28, 2026
    Report Date
    May 14, 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: 166 CM, BODY MASS INDEX (BMI) 33.7 KG/M2.

    Description of Event or Problem · 0

    A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE. IT WAS REPORTED THAT THE PATIENT RECEIVED A SINGLE ADMINISTRATION OF CEFUROXIME 1.5 GRAMS INTRAOPERATIVELY. FOUR DAYS LATER, THE PATIENT DEVELOPED A SUDDEN RISE IN INFLAMMATORY MARKERS ON BLOOD WORK, ACCOMPANIED BY ABDOMINAL PAIN AND BLOODY MUCOUS STOOLS. A STOOL SAMPLE WAS SENT TO THE LABORATORY AND RETURNED POSITIVE FOR CLOSTRIDIOIDES DIFFICILE (C. DIFFICILE). A COLONOSCOPY WAS PERFORMED, REVEALING RECTAL ANGIODYSPLASIA WITHOUT ACTIVE BLEEDING, AS WELL AS SIGMOID DIVERTICULITIS. ANTIBIOTIC THERAPY WAS INITIATED WITH CEFUROXIME AND METRONIDAZOLE; HOWEVER, LABORATORY VALUES DID NOT SHOW SIGNIFICANT IMPROVEMENT UNDER THIS REGIMEN. THE PATIENT BECAME ASYMPTOMATIC DESPITE THE PERSISTENTLY ELEVATED BLOOD WORK, AND THE OVERALL CLINICAL CONDITION WAS SATISFACTORY. THE EVENT RESULTED IN A PROLONGED HOSPITALIZATION. DISCHARGE TO HOME OCCURRED 10 DAYS AFTER THE INDEX PROCEDURE. A SUBSEQUENT OUTPATIENT FOLLOW-UP DEMONSTRATED A MARKED DECLINE IN C-REACTIVE PROTEIN (CRP), INDICATING A CLEAR TREND TOWARD RESOLUTION OF THE INFLAMMATORY PROCESS. THE EVENT WAS REPORTED AS RESOLVED SIX DAYS LATER. THE INDEX PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED INTRA-OPERATIVE COMPLICATIONS OR DA VINCI DEVICE MALFUNCTIONS. THE STUDY INVESTIGATOR REPORTED THE EVENT AS SEVERE, NOT A SERIOUS ADVERSE EVENT, A CLAVIEN-DINDO GRADE III, POSSIBLY RELATED TO THE STUDY PROCEDURE, BUT NOT RELATED TO THE DA VINCI INVESTIGATIONAL DEVICE, NOT RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS, AND NOT RELATED TO A THIRD-PARTY DEVICE. THE PATIENT'S PRIOR HEALTH HISTORY OF CERVICAL CANCER WITH RADIATION MAY BE RELEVANT TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94041 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-51 N/A 00886874110720

    Patients

    Seq Age Sex Outcome Treatment
    1