BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 22770853 · Received August 11, 2025

    Report

    Report Number
    2955842-2025-33616
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    July 16, 2025
    Report Date
    July 17, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT PRODUCT/EVENT INFORMATION. NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. THERE WAS NO REPORT OF, OR INDICATION OF, ANY DA VINCI PRODUCT ISSUES. THERE IS NO INDICATION THAT ANY DA VINCI PRODUCTS CONTRIBUTED TO THE REPORTED COMPLICATIONS. A SYSTEM LOG REVIEW WAS NOT PERFORMED SINCE THERE IS INSUFFICIENT OR UNCONFIRMED EVENT INFORMATION. CITATION: WANG, Y., LI, M., YAO, K., ZONG, Z., CHANG, Y., LIU, Y., CAI, C., KALAILAH, F., M.A., REN, S. ZENG, G., & GU, D. (2025). EXTRAPERITONEAL SINGLE-SITE ROBOT-ASSISTED RADICAL PROSTATECTOMY WITH EXTENDED PELVIC LYMPH NODE DISSECTION: TECHNIQUE AND EXPERIENCE. BJU INTERNATIONAL. HTTPS://DOI.ORG/10.1111/BJU.16670. SECTION A DEMOGRAPHIC INFORMATION: THE ALL-MALE PARTICIPANTS HAD A MEDIAN AGE OF 69 YEARS AND A MEDIAN BODY MASS INDEX (BMI) OF 21.71 KG/M2.

    Description of Event or Problem · 0

    A REVIEW OF A LITERATURE ARTICLE: EXTRAPERITONEAL SINGLE-SITE ROBOT-ASSISTED RADICAL PROSTATECTOMY WITH EXTENDED PELVIC LYMPH NODE DISSECTION: TECHNIQUE AND EXPERIENCE, IDENTIFIED ADVERSE EVENTS WITH THE DAVINCI XI SYSTEM. THE PRIMARY AIM IN THIS STUDY WAS TO DESCRIBE THE SURGICAL STEPS AND TECHNIQUE OF THE EXTRAPERITONEAL SINGLE-SITE ROBOT-ASSISTED RADICAL PROSTATECTOMY (ESSRARP) WITH EXTENDED LYMPH NODE DISSECTION (EPLND), ALONG WITH THE PRELIMINARY DATA. PATIENT DATA WAS RETRIEVED FROM PATIENTS BETWEEN JUNE 2023 AND DECEMBER 2023, 31 PATIENTS UNDERWENT ESSRARP AND EPLND. PATIENTS ELIGIBLE FOR THIS SURGICAL TECHNIQUE WERE MEN WITH HIGH-RISK LOCALIZED OR LOCALLY ADVANCED PROSTATE CANCER AND WITH A VERY HIGH RISK OF LYMPH NODE (LN) INVASION. THE ARTICLE REPORTED THAT POST-OPERATIVE COMPLICATIONS OCCURRED IN TWO PATIENTS: ONE PATIENT EXPERIENCED A DEEP VEIN THROMBOSIS REQUIRING READMISSION AND THE OTHER PATIENT DEVELOPED ACUTE EPIDIDYMITIS ON POST-OPERATIVE DAY 3, NECESSITATING PROLONGED ANTIBIOTIC THERAPY. THERE WAS NO SYMPTOMATIC LYMPHOCELE FORMATION OBSERVED. A LIMITATION TO THIS STUDY WAS A LIMITED PATIENT COHORT WITH A MEDIAN FOLLOW-UP OF 8 MONTHS. ESSRARP HAS EMERGED AS AN INTRIGUING CONCEPT. PER THE AUTHORS, ESSRARP WITH EPLND IS A SAFE AND EFFECTIVE TREATMENT OFFERING EXCELLENT SHORT-TERM OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904116 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES.