BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 25044555 · Received April 30, 2026

    Report

    Report Number
    2955842-2026-23364
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 30, 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 175 CM., BODY MASS INDEX (BMI) 25.5 KG/M2. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO). "THE PATIENT IN THIS REPORT HAD FEVER FOLLOWING THE PROCEDURE WHICH INCLUDED PLACEMENT OF MESH. ALTHOUGH THE CAUSE IS NEVER DETERMINED AND NO CLEAR EVIDENCE OF AN INFECTION IS PROVIDED, THE PATIENT WAS TREATED WITH ANTIBIOTICS AS A PROPHYLACTIC MITIGATION. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, THIS COMPLICATION IS POSSIBLY RELATED TO THE STUDY PROCEDURE BUT THERE IS NO EVIDENCE THE STUDY DEVICE OR PATIENT COMORBIDITIES CONTRIBUTED TO THIS EVENT."

    Description of Event or Problem · 0

    A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED SACROCERVICOPEXY SURGICAL PROCEDURE. TWO DAYS AFTER SURGERY, THE PATIENT DEVELOPED A FEVER OF UP TO 39.8 DEGREES CELSIUS WITH ELEVATED LEUKOCYTE LEVELS. DUE TO SUSPECTED FOREIGN BODY (MESH) REACTION, CEFUROXIME 1.5G 3 TIMES DAILY INTRAVENOUS (IV), METRONIDAZOLE 500MG TWICE DAILY IV, AND DICLOFENAC 50MG TWICE DAILY PER RECTUM HAVE BEEN ADMINISTERED PROPHYLACTICALLY AND THE HOSPITALIZATION WAS PROLONGED. FOLLOWING THIS, THE SYMPTOMS IMPROVED, AND THE INFLAMMATORY MARKERS SHOWED A DOWNWARD TREND. THE PATIENT WAS AFEBRILE WITH DECREASED LEUKOCYTE LEVELS TWO DAYS LATER, AND THE ADVERSE EVENT WAS DEEMED RESOLVED THE NEXT DAY, AT WHICH TIME THE PATIENT WAS DISCHARGED. THE INDEX PROCEDURE WAS COMPLETED WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS, AND THERE WERE NO DA VINCI DEVICE MALFUNCTIONS. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MILD SEVERITY, NOT A SERIOUS ADVERSE EVENT, A CLAVIEN-DINDO GRADE II, POSSIBLY RELATED TO THE STUDY PROCEDURE, BUT NOT RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS, NOT RELATED TO THE DA VINCI INVESTIGATIONAL DEVICE, AND NOT RELATED TO A THIRD-PARTY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508364 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-43 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES