BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 22865051 · Received August 21, 2025

    Report

    Report Number
    2955842-2025-34881
    Event Type
    Injury
    Date Received
    August 21, 2025
    Date of Event
    June 5, 2025
    Report Date
    July 30, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    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 WAS INSUFFICIENT OR UNCONFIRMED EVENT INFORMATION. CITATION: FAN, Y., DONG, J., WANG, H., ZU, Q., LIU, K., ZHU, J., WANG, B., HUANG, Q., GAO, Y., CHEN, X., ZHAO, J., HAO, X., ZHU, Q., HUANG, S., MA, X., & ZHANG, X. (2025). BENCH SURGERY WITH ROBOT-ASSISTED KIDNEY AUTOTRANSPLANTATION FOR COMPLEX KIDNEY TUMORS: TECHNIQUE AND OUTCOMES FROM A SINGLE CENTER. EUROPEAN UROLOGY OPEN SCIENCE, 74, 1¿10. HTTPS://DOI.ORG/10.1016/J.EUROS.2025.01.018. PATIENT DEMOGRAPHIC INFORMATION: AGE: MEDIAN INTERQUARTILE RANGE (IQR) 47 TO 57 YEARS. GENDER: FEMALE (10) AND MALE (14); BODY MASS INDEX (BMI): MEDIAN IQR 24.4 (22.4¿26.1) KG/M2.

    Description of Event or Problem · 0

    A REVIEW OF A LITERATURE ARTICLE "BENCH SURGERY WITH ROBOT-ASSISTED KIDNEY AUTO-TRANSPLANTATION FOR COMPLEX KIDNEY TUMORS: TECHNIQUE AND OUTCOMES FROM A SINGLE CENTER" WAS PERFORMED. FROM JANUARY 2018 TO MAY 2021, FOUR PATIENTS WITH SOLITARY KIDNEY TUMORS AND EIGHT WITH BILATERAL KIDNEY TUMORS UNDERWENT BENCH SURGERY (BENS) AND ROBOT-ASSISTED KIDNEY AUTO-TRANSPLANTATION (RAKAT). THE ARTICLE NOTED THAT THAT DURING THESE DV SURGERIES, "THREE PATIENTS PRESENTED GRADE IV POSTOPERATIVE COMPLICATIONS, AS FOLLOWS: ONE DEVELOPED SEPTIC SHOCK THAT RESOLVED WITH TREATMENT WITH BROAD-SPECTRUM ANTIBIOTICS AND SUPPORTIVE CARE IN THE INTENSIVE CARE UNIT. WHILE OTHER TWO OTHER DEVELOPED DELAYED GRAFT FUNCTION (DGF) THAT RESOLVED WITH TEMPORARY DIALYSIS." THE AUTHORS CONCLUDED THAT BENS WITH RAKAT IS AN ALTERNATIVE STRATEGY FOR THE TREATMENT OF HIGH-COMPLEXITY RENAL TUMORS THAT ARE UNSUITABLE FOR IN SITU PARTIAL NEPHRECTOMY (PN). LARGER PROSPECTIVE STUDIES WITH LONGER FOLLOW-UP ARE REQUIRED TO FURTHER ASSESS THE FINDINGS. THERE WERE NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS REPORTED, NOR DID THE AUTHOR ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. INTUITIVE SURGICAL INC. (ISI) HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, AS OF THE DATE OF THIS REPORT, NO NEW INFORMATION HAS BEEN OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2409727 DA VINCI SURGICAL SYSTEM DA VINCI SURGICAL SYSTEMS NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

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