BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUGO¿ RAS SYSTEM

    MDR report key: 24145273 · Received January 22, 2026

    Report

    Report Number
    1219930-2026-00406
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    December 30, 2025
    Report Date
    April 14, 2026
    Manufacturer
    SURGICAL
    Product Code
    SCV
    UDI-DI
    10884521836242
    PMA / PMN Number
    K250725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3 AND H6: ANNEX B, ANNEX C, ANNEX D. ANNEX G HAVE BEEN AMENDED. DEVICE EVALUATION: MEDTRONIC LED AN EVALUATION OF THE FIELD SERVICE NOTES AND ASSOCIATED DEVICE DATA FOR THE REPORTED ARM CART ASSEMBLY (ACA). REVIEW OF THE FIELD SERVICE NOTES INDICATES THAT THE Z-SLIDE WAS REPLACED TO RESOLVE THE ISSUE. EVALUATION OF THE DEVICE DATA INDICATES THAT THE LOGS ARE NOT ABLE TO TRACK HARDWARE ISSUES. EVALUATION OF THE ARM CART ASSEMBLY CONFIRMED THE REPORTED CONDITION. THE ROOT CAUSE OF THE OBSERVED INSTRUMENT DRIVE UNIT (IDU) MOVEMENT ISSUE ON THE ARM CART ASSEMBLY WAS DETERMINED TO BE AN ISSUE WITH THE Z-SLIDE RELATED TO A JOINT FORCE SENSOR (JFS) OFFSET. A PROCESS IMPROVEMENT WITH THE SUPPLIER HAS BEEN INITIATED TO ADDRESS THIS ISSUE. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. 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.

    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 THAT, PRE-OPERATIVELY, THE INSTRUMENT DRIVE UNIT (IDU) EXHIBITED STIFFNESS WHEN MOVING DOWNWARD TOWARDS TROCAR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, PRE-OPERATIVELY, THE INSTRUMENT DRIVE UNIT (IDU) EXHIBITED STIFFNESS WHEN MOVING DOWNWARD TOWARDS TROCAR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578881 HUGO¿ RAS SYSTEM MODULAR ELECTROMECHANICAL SURGICAL SYSTEM SCV SURGICAL MRASC0002 10884521836242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown MRASC0002 SN: (B)(6)