BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 24621169 · Received March 17, 2026

    Report

    Report Number
    2955842-2026-16043
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    April 25, 2025
    Report Date
    February 20, 2026
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    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

    NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY INTUITIVE SURGICAL, INC. (ISI) DEVICE. NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. CITATION: ANGERER, M., ET AL. (2025). FEASIBILITY AND ONCOLOGICAL SAFETY OF ROBOTIC RETROPERITONEAL LYMPH NODE DISSECTION IN PATIENTS WITH TESTICULAR CANCER - SINGLE-CENTER EXPERIENCE. CANCERS, 17, 1439. HTTPS://DOI.ORG/10.3390/CANCERS17091439. SECTION A2: PATIENT INFORMATION AGE: REFLECTS THE STUDY MEAN AGE OF THE PATIENTS IN THE ROBOTIC GROUP. SECTION A3A- PATIENT GENDER REPRESENTS THE MAJORITY OF THE PATIENTS IN THE ROBOTIC GROUP. SECTION B7: THE PATIENT'S MEDICAL HISTORY IS UPDATED PER THE MAJORITY OF THE PATIENT'S CHARACTERISTICS IN THE ROBOTIC GROUP COHORT. SECTION D: THE PROCEDURES IN THE ARTICLE WERE PERFORMED ON BOTH DA VINCI XI AND S SYSTEMS. THERE WAS NO DIFFERENTIATION PROVIDED REGARDING WHICH SYSTEM WAS USED PER PROCEDURE. 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 OF AN ARTICLE THAT AIMED TO COMPARE THE SAFETY AND ONCOLOGICAL OUTCOMES OF OPEN (O-RPLND) AND ROBOTIC (R-RPLND) RETROPERITONEAL LYMPH NODE DISSECTION FOR TESTICULAR CANCER WAS PERFORMED. THE STUDY ANALYZED THIRTY-ONE (47.7%) PATIENTS WHO UNDERWENT R-RPLND BETWEEN 2017 AND 2024. A TOTAL OF 2 PATIENTS EXPERIENCED COMPLICATIONS, INCLUDING ONE PATIENT WHO REQUIRED THE OVERSEWING OF THE VENA CAVA INTRAOPERATIVELY (CLAVIEN-DINDO IIIA). NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY INTUITIVE SURGICAL, INC. (ISI) DEVICE. ISI MADE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624904 DA VINCI DA VINCI SURGICAL SYSTEM NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES