BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 21934229 · Received April 30, 2025

    Report

    Report Number
    2955842-2025-17338
    Event Type
    Injury
    Date Received
    April 30, 2025
    Date of Event
    October 17, 2024
    Report Date
    April 3, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: XU, Z., QIN, H., YU, M., ZHANG, Q., LI, X., GUO, H., & LIU, G. (2024). CLINICAL APPLICATION AND EFFICACY ANALYSIS OF ROBOT-ASSISTED LAPAROSCOPIC TUMOR ENUCLEATION COMBINED WITH TUMOR ASPIRATION IN THE TREATMENT OF RENAL HILAR ANGIOMYOLIPOMA. BMC UROLOGY, 24(1). HTTPS://DOI.ORG/10.1186/S12894-024-01623-4. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. THERE WERE 6 MALES AND 32 FEMALES, WITH THE AVERAGE OF AGE (49.1±12.7) YEARS, BODY MASS INDEX (24.2±2.9) KG/M².

    Description of Event or Problem · 0

    A LITERATURE ARTICLE DESCRIBED A RETROSPECTIVE STUDY THAT AIMED TO EVALUATE THE IMPACT OF CLINICAL APPLICATION AND EFFICACY ANALYSIS OF ROBOT-ASSISTED LAPAROSCOPIC TUMOR ENUCLEATION COMBINED WITH TUMOR ASPIRATION IN THE TREATMENT OF RENAL HILAR ANGIOMYOLIPOMA. THERE WERE 38 PATIENTS WITH RENAL HILAR ANGIOMYOLIPOMA (RAML) WHO WENT THROUGH ROBOTIC TUMOR ENUCLEATION COMBINED WITH TUMOR ASPIRATION FROM DECEMBER 2019 TO DECEMBER 2022. ALL PATIENTS UNDERWENT SURGICAL PROCEDURES USING THE DA VINCI XI SYSTEM, AND THE TRANSPERITONEAL APPROACH WAS ADOPTED. THE ARTICLE NOTED THAT DURING THESE DV SURGERIES, ONE PATIENT DEVELOPED URINARY EXTRAVASATION 10 DAYS AFTER SURGERY, COMPLAINING OF ABDOMINAL PAIN WITH LOW-GRADE FEVER. THE PHYSICAL EXAMINATION REVEALED MILD TENDERNESS IN THE AFFECTED ABDOMEN; HOWEVER, RE-EXAMINATION OF THE COMPUTED TOMOGRAPHY UROGRAPHY (CTU) SHOWED LEAKAGE OF THE CONTRAST AGENT. THEREFORE, THE PATIENT WAS DIAGNOSED WITH AN INJURY OF THE RENAL PELVIS COLLECTING SYSTEM (CLAVIEN-DINDO GRADE IIIB). HE WAS READMITTED TO THE HOSPITAL FOR TRANSURETHRAL DOUBLE J URETERAL STENT IMPLANTATION, WHICH WAS COMPLETED. AFTER ONE WEEK, THE URINARY COMPUTED TOMOGRAPHY (CT) SCAN SHOWED THAT THE EXTRAVASATED URINE WAS SIGNIFICANTLY REDUCED, AND THE URETERAL STENT WAS REMOVED TWO MONTHS LATER. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO THE EVENT. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION FROM THE DESIGNATED AUTHOR WERE MADE, BUT NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967793 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652-46 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Hospitalization| R DA VINCI INSTRUMENTS AND ACCESSORIES.