BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUGO¿ RAS SYSTEM

    MDR report key: 24674329 · Received March 24, 2026

    Report

    Report Number
    1219930-2026-01904
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    February 26, 2026
    Report Date
    April 24, 2026
    Manufacturer
    SURGICAL
    Product Code
    SCV
    UDI-DI
    10884521836242
    PMA / PMN Number
    K250725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 0

    H3 AND H6: ANNEX B, ANNEX C AND ANNEX G HAVE BEEN UPDATED. DEVICE EVALUATION: MEDTRONIC LED AN EVALUATION OF THE FIELD SERVICE NOTES FOR THE REPORTED ARM CART ASSEMBLY (ACA). REVIEW OF THE FIELD SERVICE NOTES SHOWS THE JOINT FORCE SENSOR (JFS) CALIBRATION PROCEDURE WAS PERFORMED TWICE ON THE ACA TO RESOLVE THE ISSUE. EVALUATION OF THE ARM CART ASSEMBLY CONFIRMED THE REPORTED CONDITION, HOWEVER, THE INVESTIGATION CONCLUDED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION; THEREFORE, THE INVESTIGATION WAS NOT ABLE TO IDENTIFY A ROOT CAUSE. HOWEVER, THE MOST LIKELY CAUSE COULD BE TRACED TO THE INSTRUMENT DRIVE UNIT (IDU) OF THE ARM CART ASSEMBLY. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE INSTRUMENT DRIVE UNIT(IDU) OF ARM CART ASSEMBLY (ACA) EXHIBITED A MOVEMENT ERROR, SPECIFICALLY IDU MOVING UP WHEN THE BUTTON WAS PRESSED. IT TOOK AROUND 2 HOURS TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE INSTRUMENT DRIVE UNIT (IDU) EXHIBITED A MOVEMENT ERROR, SPECIFICALLY IDU MOVING UP WHEN THE BUTTON WAS PRESSED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257219 HUGO¿ RAS SYSTEM MODULAR ELECTROMECHANICAL SURGICAL SYSTEM SCV SURGICAL MRASC0002 10884521836242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown