BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI X

    MDR report key: 24376907 · Received February 18, 2026

    Report

    Report Number
    2955842-2026-04674
    Event Type
    Injury
    Date Received
    February 18, 2026
    Date of Event
    January 12, 2026
    Report Date
    February 18, 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. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO): "THIS PATIENT HAD A HISTORY MULTIPLE PRIOR OPERATIONS AND UNDERWENT A HYSTERECTOMY. WHILE NO INTRAOPERATIVE ISSUES WERE NOTED, SHE HAD A POSTOPERATIVE ISSUE WITH CONSTIPATION AND DIFFICULTY STOOLING. SHE ALSO UNDERWENT AN ADHESIOLYSIS WHICH SUGGESTS THE PROBLEM WAS MORE THAN JUST FUNCTIONAL CONSTIPATION AND A MECHANICAL ISSUE ALSO EXISTED. HOW EACH OF THESE ISSUES MAY HAVE INDIVIDUALLY OR COLLECTIVELY CONTRIBUTED TO THE POST-OPERATIVE COURSE IS NOT PROVIDED. THEREFORE, THIS COMPLICATION IS POSSIBLY RELATED TO THE STUDY PROCEDURE AND ALSO POSSIBLY RELATED TO THE PATIENT¿S UNDERLYING DISEASE INCLUDING PRIOR SURGICAL HISTORY. THERE IS NO EVIDENCE TO SUGGEST THIS COMPLICATION IS RELATED TO THE STUDY DEVICE." ADDITIONAL PATIENT INFORMATION: HEIGHT 180 CM., BODY MASS INDEX (BMI) 23.5 KG/M2.

    Description of Event or Problem · 0

    A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED SACROCOLPOPEXY WITH HYSTERECTOMY AND SALPINGECTOMY SURGICAL PROCEDURE. TWENTY-TWO DAYS AFTER DISCHARGE, THE PATIENT WAS REFERRED FOR FURTHER EVALUATION DUE TO LOWER ABDOMINAL PAIN. SHE REPORTED SHARP BACK PAIN ON DEEP INSPIRATION FOR THE PRECEDING TWO DAYS, ALONG WITH INCREASING CONSTIPATION SINCE THE SURGERY. BOWEL MOVEMENTS WERE ONLY POSSIBLE WITH THE USE OF MOVICOL. DICLOFENAC 100MG WAS TAKEN FOR PAIN RELIEF, BUT WITHOUT MEANINGFUL IMPROVEMENT. THE ABDOMINAL PAIN CONTINUED TO INTENSIFY, AND IT WAS REPORTED THAT THE SYMPTOMS PERSISTED EVEN AT HOME DURING PERIODS OF REST. SEVEN DAYS AFTER THE REFERRAL, THE PATIENT UNDERWENT ADHESIOLYSIS FOR OBSTIPATION; DISCHARGE OCCURRED THE SAME DAY. THE INDEX PROCEDURE WAS COMPLETED WITHOUT REPORTED INTRA-OPERATIVE COMPLICATIONS; THERE WERE NO DA VINCI DEVICE MALFUNCTIONS REPORTED. DISCHARGE OCCURRED TWO DAYS AFTER THE INDEX PROCEDURE. THE STUDY INVESTIGATOR REPORTED THE EVENT AS MODERATE SEVERITY, NOT A SERIOUS ADVERSE EVENT, A CLAVIEN-DINDO GRADE IIIB, PROBABLY RELATED TO THE STUDY PROCEDURE, POSSIBLY RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS, NOT RELATED TO THE DA VINCI INVESTIGATIONAL DEVICE, AND NOT RELATED TO A THIRD-PARTY DEVICE. THE PATIENT'S PRIOR HEALTH CONDITION OF ENDOMETRIOSIS AND MANY PRIOR OPERATIONS MAY BE RELEVANT TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438290 DAVINCI X PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380620-43 N/A 00886874115404

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES