BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI

    MDR report key: 24604437 · Received March 16, 2026

    Report

    Report Number
    2955842-2026-16006
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    March 21, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SPECIFIC DA VINCI DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHOR DID NOT ALLEGE THAT INTUITIVE SURGICAL, INC. (ISI) PRODUCTS CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENT. NO INVESTIGATION COULD BE PERFORMED AS THE ARTICLE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE PROCEDURE DATE OR DA VINCI SYSTEM IDENTIFIERS. CITATION: GHOREIFI, A., ET AL. (2025). THE OUTCOMES OF SALVAGE ROBOTIC RADICAL PROSTATECTOMY FOLLOWING RADIATION VERSUS FOCAL THERAPY: DOES THE PRIMARY TREATMENT MODALITY MATTER? BJUI COMPASS, 6, E70019. HTTPS://DOI.ORG/10.1002/BCO2.70019 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 SI 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 COMPARED SALVAGE ROBOTIC RADICAL PROSTATECTOMY (SRRP) FOR RECURRENT PROSTATE CANCER (PCA) AFTER PRIMARY RADIATION (RT) VERSUS FOCAL THERAPY (FT). WAS PERFORMED. THE STUDY ANALYZED 112 PATIENTS UNDERGOING SALVAGE ROBOTIC RADICAL PROSTATECTOMY BETWEEN JANUARY 2010 AND DECEMBER 2022. A TOTAL OF 31 PATIENTS EXPERIENCED COMPLICATIONS, INCLUDING BLADDER NECK CONTRACTURE, LYMPHOCELE, RECTAL INJURY REQUIRING INTRAOPERATIVE REPAIR, URINE LEAK, HEMATURIA, ACUTE URINARY RETENTION, DEEP VEIN THROMBOSIS, URINARY TRACT INFECTION, AND SURGICAL SITE INFECTION. THE ARTICLE ADDITIONALLY REPORTED LOW HEMOGLOBIN REQUIRING TRANSFUSION. NO DEVICE MALFUNCTIONS WERE REPORTED, AND THE AUTHORS DID NOT REPORT ANY EVENTS CAUSED BY ANY ISI DEVICE. ISI MADE MULTIPLE 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
    269778 DA VINCI DA VINCI SURGICAL SYSTEM NAY INTUITIVE SURGICAL, INC N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention| H DA VINCI INSTRUMENTS AND ACCESSORIES