BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI XI

    MDR report key: 24600377 · Received March 14, 2026

    Report

    Report Number
    2955842-2026-15766
    Event Type
    Injury
    Date Received
    March 14, 2026
    Date of Event
    January 28, 2019
    Report Date
    February 17, 2026
    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
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SYSTEM LOG REVIEW CANNOT BE PERFORMED DUE TO INSUFFICIENT INFORMATION PROVIDED. NO DA VINCI SYSTEM IDENTIFIERS WERE PROVIDED. CITATION: KILIC, S., ET AL. (2025). COMPARATIVE ANALYSIS OF ROBOT-ASSISTED VERSUS TRADITIONAL LAPAROSCOPIC RETROPERITONEAL PARTIAL NEPHRECTOMY. VAN MEDICAL JOURNAL, 32(1), 21-26. HTTPS://DOI.ORG/10.5505/VMJ.2025.42650. NOTE: REFER TO MEDWATCH REPORT (MDR) WITH MFR. REPORT #2955842-2026-15771 FOR MDR SUBMISSION OF THE PROLONGED POST-OPERATIVE URINARY LEAKAGE REQUIRING SURGICAL INTERVENTION NOTED WITHIN THE ARTICLE. SECTION B7: THE PATIENT'S MEDICAL HISTORY IS UPDATED PER THE MAJORITY OF THE PATIENT'S CHARACTERISTICS IN THE ROBOTIC GROUP COHORT. SECTION D: DUE TO THE LACK OF SPECIFIC INFORMATION REGARDING THE DA VINCI SYSTEM ASSOCIATED WITH THE ADVERSE EVENT, A GENERIC SYSTEM MATERIAL NUMBER WAS USED. SECTION E: THE EVENT SITE IS RECORDED BASED ON THE LOCATION OF THE FIRST AUTHOR'S ASSOCIATED HOSPITAL. WHILE THE EXACT SITE IS UNKNOWN, THIS DESIGNATION IS CONSIDERED AN APPROPRIATE SUBSTITUTION. SECTION E: SINCE THIS ARTICLE WAS IDENTIFIED DURING A LITERATURE REVIEW BY ISI, RATHER THAN REPORTED BY THE SITE, THE CORRESPONDING AUTHOR IS DESIGNATED AS THE INITIAL REPORTER OF THE EVENT.

    Description of Event or Problem · 0

    A REVIEW WAS CONDUCTED OF AN ARTICLE THAT EVALUATED THE EFFECTIVENESS OF LAPAROSCOPIC RETROPERITONEAL PARTIAL NEPHRECTOMY (LRPN) AND ROBOT-ASSISTED RETROPERITONEAL PARTIAL NEPHRECTOMY (RRPN) IN MANAGING RENAL TUMORS, WITH A FOCUS ON PERIOPERATIVE EFFICIENCY, ONCOLOGICAL SAFETY, AND PRESERVATION OF RENAL FUNCTION. THE RETROSPECTIVE COHORT STUDY ANALYZED A TOTAL OF 80 PATIENTS, 54 OF WHICH UNDERWENT RRPN PATIENTS BETWEEN JANUARY 2019 AND NOVEMBER 2023. ONE PATIENT EXPERIENCED AN INTRAOPERATIVE URETER INJURY REQUIRING REPAIR. ONE PATIENT IN EACH GROUP EXPERIENCED PROLONGED POST-OPERATIVE URINARY LEAKAGE THAT WAS TREATED WITH INSERTION OF A D-J STENT. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY INTUITIVE SURGICAL, INC. (ISI) DEVICE. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PHYSICIAN INDICATED THAT NO DA VINCI DEVICE MALFUNCTIONS OCCURRED IN THE PROCEDURES MENTIONED IN THE ARTICLE AND THE REPORTED COMPLICATIONS ARE NOT RELATED TO THE DA VINCI ROBOTIC SURGICAL SYSTEM BUT ARE RELATED TO THE SURGICAL TECHNIQUE. THE PHYSICIAN FURTHER STATED: "POSTOPERATIVE URINARY LEAKAGE, AS STATED IN THE ARTICLE, DEVELOPED IN A PATIENT WHO UNDERWENT PARTIAL NEPHRECTOMY WITHOUT SUTURELESS TECHNIQUE (RENOGRAPHY) AND IS A COMPLICATION ENTIRELY DEPENDENT ON THE SUTURELESS SURGICAL TECHNIQUE. THE PATIENT WITH URINE LEAKAGE IS A 29-YEAR-OLD TURKISH MAN WITH A BMI OF 24 AND WAS OPERATED ON 19.10.2022. THE PATIENT WITH URETER INJURY IS A 41-YEAR-OLD TURKISH WOMAN WITH A BMI OF 27, WHO UNDERWENT SURGERY ON JANUARY 28, 2019."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361172 DAVINCI XI PATIENT SIDE CART, 4-ARM NAY INTUITIVE SURGICAL, INC 380652 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention| H DA VINCI INSTRUMENTS AND ACCESSORIES.