BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUGO? RAS

    MDR report key: 24349619 · Received February 16, 2026

    Report

    Report Number
    1219930-2026-00959
    Event Type
    Injury
    Date Received
    February 16, 2026
    Date of Event
    December 29, 2025
    Report Date
    February 16, 2026
    Manufacturer
    SURGICAL
    Product Code
    SCV
    PMA / PMN Number
    K250725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH LITERATURE THAT A PROSPECTIVE STUDY BETWEEN JUNE 2023 AND SEPTEMBER 2024 EVALUATED PERIOPERATIVE SAFETY AND SURGICAL TEAM ADAPTATION TO THE HUGO RAS PLATFORM. THERE WERE 100 PATIENTS INCLUDED IN THE STUDY THAT UNDERWENT EXTRAPERITONEAL ROBOT-ASSISTED RADICAL PROSTATECTOMY. FIVE PATIENTS HAD SERIOUS INJURIES INCLUDING THREE PATIENTS THAT REQUIRED BLOOD/BLOOD PRODUCT TRANSFUSIONS, ONE PATIENT WITH A CYSTOSTOMY AND ONE PATIENT WITH BILATERAL PERCUTANEOUS NEPHROSTOMY. FOURTEEN PATIENTS EXPERIENCED UNSPECIFIED POSTOPERATIVE COMPLICATIONS. "EXTRAPERITONEAL ROBOT-ASSISTED RADICAL PROSTATECTOMY WITH THE HUGO¿ RAS SYSTEM: 100 CONSECUTIVE CASES, 1-YEAR FOLLOW-UP AND SURGICAL LEARNING CURVE EVALUATION", AUTHORS: MARCELLO SCARCIA, GIOVANNI BATTISTA FILOMENA, MARCO MONTESI, NICOLETTA TESTORI, PIERLUIGI RUSSO, STEFANO MORETTO, SIMONE COTRUFO, FRANCESCO PAOLO MASELLI, FILIPPO GAVI, FRANCESCO PIO BIZZARRI, ROBERTO CALBI, ALBA FIORENTINO, FILIPPO MARINO, MARIA CHIARA SIGHINOLFI, BERNARDO MARIA ROCCO, LUIGI CORMIO, GIUSEPPE MARIO LUDOVICO, MICHELE ZAZZARA. JOURNAL OF ROBOTIC SURGERY, PUBLISHED 29 DECEMBER 2025, HTTPS://DOI.ORG/10.1007/S11701-025-03092-9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406720 HUGO? RAS MODULAR ELECTROMECHANICAL SURGICAL SYSTEM SCV SURGICAL MRASC0001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R