BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SP

    MDR report key: 24337532 · Received February 13, 2026

    Report

    Report Number
    2955842-2026-04235
    Event Type
    Injury
    Date Received
    February 13, 2026
    Date of Event
    January 21, 2026
    Report Date
    April 9, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114605
    PMA / PMN Number
    K182371
    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 172 CM.; BODY MASS INDEX (BMI) 24.0 KG/M2.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) MEDICAL SAFETY OFFICER (MSO) CONCLUDED THAT THE ADVERSE EVENT DESCRIBED IS NOT UNIQUE TO AN ISI PRODUCT AND THE ISI PRODUCT COULD NOT HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT; HOWEVER, THERE IS A PROBABLE RELATIONSHIP TO THE STUDY PROCEDURE. PER THE MSO, "THE PATIENT IN THIS REPORT DEVELOPED AN INFECTION REQUIRING ANTIBIOTICS WHICH RESOLVED AFTER A SHORT COURSE OF THERAPY. THE SOURCE OF THE INFECTION WAS NOT REPORTED. BASED ON THE INFORMATION PROVIDED IN THE SUMMARY OF EVENTS, THIS COMPLICATION WAS MOST LIKELY RELATED TO THE PROCEDURE ALTHOUGH THIS PATIENT¿S MULTIPLE PRIOR PROCEDURES AND COMORBIDITIES MAY HAVE BEEN CONTRIBUTING FACTORS. THERE IS NO EVIDENCE THIS COMPLICATION WAS RELATED TO THE STUDY DEVICE."

    Description of Event or Problem · 0

    A PATIENT IN A STUDY UNDERWENT A DA VINCI-ASSISTED PELVIC AND PARAAORTIC LYMPHADENECTOMY PROCEDURE. ONE WEEK AFTER THE INDEX PROCEDURE, A POST-DISCHARGE INFECTION WITH FEVER AND LOWER ABDOMINAL PAIN WAS REPORTED REQUIRING AN UNSPECIFIED ANTIBIOTIC AND REHOSPITALIZATION FOR ONE WEEK, AT ANOTHER HOSPITAL. THE EVENT WAS REPORTED AS RESOLVED ONE WEEK LATER. THE INDEX PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED ADVERSE EVENTS, OR INJURIES. NO MALFUNCTIONS INVOLVING THE DA VINCI SYSTEM, ITS ACCESSORIES, OR ITS INSTRUMENTS WERE REPORTED. DISCHARGE OCCURRED ON AN UNSPECIFIED DATE. THE STUDY INVESTIGATOR REPORTED THE EVENT AS SEVERE, A SERIOUS ADVERSE EVENT (REQUIRING MEDICAL OR SURGICAL INTERVENTION), A CLAVIEN-DINDO GRADE II, HAVING A PROBABLE RELATIONSHIP TO THE STUDY PROCEDURE, BUT NOT RELATED TO THE DA VINCI INVESTIGATIONAL DEVICE, NOT RELATED TO A THIRD-PARTY DEVICE, AND NOT RELATED TO THE PATIENT'S UNDERLYING DISEASE STATUS.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371756 DA VINCI SP PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380601-50 N/A 00886874114605

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES.