BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUGO¿ RAS SYSTEM

    MDR report key: 25306460 · Received May 27, 2026

    Report

    Report Number
    1219930-2026-03369
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 12, 2026
    Report Date
    May 27, 2026
    Manufacturer
    SURGICAL
    Product Code
    SCV
    UDI-DI
    10884521826625
    PMA / PMN Number
    K250725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS LEADING AN EVALUATION OF THE REPORTED SURGEON CONSOLE.. REVIEW OF THE FIELD SERVICE NOTES INDICATE THAT THE SURGEON CONSOLE (SC) LOST COMMUNICATION. THE FOLLOWING ERROR CODES WERE OBSERVED: 'CENTRAL SAFETY MONITOR - LOST SURGEON CONSOLE SAFETY LOCAL', 'COMMUNICATION LOSS: MAIN SYSTEM CONTROLLER ERROR HANDLER - SURGEON CONSOLE, 'SURGEON CONSOLE NON-RECOVERABLE ERROR__SURGEON CONSOLE NON-RECOVERABLE ERROR; SURGEON CONTROL DISABLED_CONSOLE COMPUTING NODE COMM LOST', 'CONSOLE SURGEON CONSOLE MASTER CONTROLLER COMM FAIL', 'CLIENT COMMUNICATION LOSS', AND 'LOCAL ALARMS COMMS LOSS - SURGEON CONSOLE'. THE ISSUE WAS ALSO DISCUSSED WITH THE GSE GLOBAL SERVICE ENGINEER TEAM FOR FURTHER ANALYSES AND THE ABOVE ERROR CODES ARE RELATED TO A LOSS OF COMMUNICATION WITH THE SURGEON CONSOLE MASTER CONTROLLER. THE FIELD SERVICE ENGINEER ON THE SITE CHECKED CABLE CONNECTION OF THE SURGEON CONSOLE MASTER CONTROLLER AND FOUND THAT TWO UNIVERSAL SERIAL BUS CABLES WERE LOOSE. THE RESPECTIVE CABLES WERE RESEATED TO RESOLVE THE ISSUE. EVALUATION OF THE ONE IMAGE PROVIDED WHICH SHOWS THE ERROR MESSAGES RELATED TO THE SURGEON CONSOLE SC ON THE OPERATING ROOM TEAM INTERACTIVE SCREEN OF THE TOWER. THE ERROR MESSAGES ARE: "WARNING : SURGEON CONSOLE NON-RECOVERABLE ERROR. RESTART SURGEON CONSOLE. IF ERROR REOCCURS, CONTINUE FROM BEDSIDE OR DISCONTINUE SYSTEM USE.", "WARNING : SURGEON CONSOLE NON-RECOVERABLE ERROR. RESTART SURGEON CONSOLE. IF ERROR REOCCURS, CONTINUE FROM BEDSIDE OR DISCONTINUE SYSTEM USE.", "WARNING : SURGEON CONSOLE COMMUNICATION LOST. CHECK DATA CABLE OR RESTART CONSOLE USING RED AC POWER SWITCH. TOUCH DISMISS TO ACKNOWLEDGE.", AND "CAUTION : SURGEON CONSOLE COMMUNICATION LOST. CHECK CONSOLE DATA CABLE. IF ERROR PERSISTS, RESTART SURGEON CONSOLE." FURTHER EVALUATION OF THE REPORTED SURGEON CONSOLE IS STILL PENDING, AND THE INVESTIGATION IS NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REGULATORY REPORT WHEN THE INVESTIGATION IS COMPLETE. 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 THAT, DURING A ROBOTIC LAPAROSCOPIC RIGHT NEPHRECTOMY, THE SURGEON CONSOLE LOST CONNECTION WITH THE SYSTEM MULTIPLE TIMES THROWING A NON-RECOVERABLE ERROR. THIS OCCURRED BOTH BEFORE BEGINNING THE PROCEDURE AND DURING THE PROCEDURE. THE STARTUP SPECIALIST (SUS) REBOOTED THE SURGEON CONSOLE TWICE BOTH TIMES THE ISSUE OCCURRED TO RESOLVE THE ISSUE SINCE THE SURGEON DID NOT WANT TO CANCEL OR POSTPONE THE SURGERY. THERE WAS A DELAY OF ROUGHLY 15 MINUTES. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339500 HUGO¿ RAS SYSTEM MODULAR ELECTROMECHANICAL SURGICAL SYSTEM SCV SURGICAL MRASC0001 10884521826625

    Patients

    Seq Age Sex Outcome Treatment
    1