BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUGO¿ RAS SYSTEM

    MDR report key: 24492349 · Received March 2, 2026

    Report

    Report Number
    1219930-2026-01407
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    February 13, 2026
    Report Date
    April 22, 2026
    Manufacturer
    SURGICAL
    Product Code
    SCV
    UDI-DI
    10884521826632
    PMA / PMN Number
    K250725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 AND H6: ANNEX B, ANNEX C , ANNEX D AND ANNEX G HAVE BEEN UPDATED. 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 SHOWS THAT REVIEW OF THE LOGS REVEALED THAT THE ARM FAILED FOLLOWING THE OUTPUT OF ERROR CODES ¿ROBOTIC ARM (RA) JOINT FORCE SENSOR (JFS) MARKED INVALID¿ AND ¿RA_J5 (JOINT 5) JFS POWER SUPPLY ERROR¿. THESE ERRORS RECURRED AFTER REBOOTING THE ARM. THE INSTRUMENT DRIVE UNIT (IDU) WAS RESEATED TO RESOLVE THE ISSUE. EVALUATION OF THE DEVICE DATA INDICATES A ROBOTIC ARM JOINT 5 (RA_J5) JOINT POSITION SENSOR (JPS) POWER SUPPLY ERROR WAS TRIGGERED AND CAUSED THE RA_J5 JFS READINGS TO BE INVALID, TRIGGERING ERRORS. ONE OF THE ERRORS REPORTS A NON-RECOVERABLE INOPERABLE ERROR THAT REQUIRES THE ACA TO BE REBOOTED TO REGAIN POSITION CONTROL AND MANUAL CONTROL. THE POSITION BUTTON WAS PRESSED AND ONLY RELEASED AFTER THE ERRORS OCCURRED, POINTING TO THE REPORTED RECKLESS MOVEMENT OF THE ARM FROM THE USER. THE ACA WAS RESTARTED THREE TIMES AND FAILED CALIBRATION EACH TIME DUE TO THE ERROR CODE. EVALUATION OF THE DEVICE DATA FOR THE REPORTED ARM CART ASSEMBLY CONFIRMED THE REPORTED CONDITION. THE ROOT CAUSE OF THE OBSERVED ERRORS WAS DETERMINED TO BE RELATED TO CONNECTIVITY ISSUES BETWEEN THE Z-SLIDE AND INSTRUMENT DRIVE UNIT (IDU). THIS IS TRACED TO DEVICE DESIGN SUCH AS SMALL MOVEMENTS IN THE CONNECTOR DUE TO IMPACT OR AN INADEQUATE STRAIN RELIEF THAT CAUSE THE CONTACTS TO SHIFT ONTO REGIONS OF THE MATING CONTACTS THAT ARE CONTAMINATED WITH FLUX, WHICH PREVENTS ELECTRICAL CONDUCTIVITY. ADDITIONALLY, DAMAGE TO THE ASSEMBLY FIXTURE PIN ALLOWED TOO MUCH INTERFERENCE BETWEEN CONNECTOR COMPONENTS, LEADING TO CONNECTOR DAMAGE AND LOSS OF CONNECTIVITY. IMPROVEMENTS HAVE BEEN INITIATED TO MITIGATE THIS CONDITION. 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 POST-OPERATIVELY, AFTER UNDOCKING, THE ASSISTANT WAS MOVING THE ARM AWAY FROM THE BEDSIDE USING THE POSITION BUTTON. DURING THIS PROCESS, THE ARM HIT ITSELF AS THE ASSISTANT MOVED IT RECKLESSLY, CAUSING THE ARM TO BECOME INOPERATIVE AND THE BEDSIDE CONTROL COULD NOT BE USED. THE ISSUE PERSISTED EVEN AFTER RESTARTING THE ARM THREE TIMES. TO RESOLVE THE ISSUE THE INSTRUMENT DRIVE UNIT (IDU) WAS RESEATED AND BRAKE REGEN ON SETUP ARM_JOINT 4 (SAJ4) WAS PERFORMED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT POST-OPERATIVELY, AFTER UNDOCKING, THE ASSISTANT WAS MOVING THE ARM AWAY FROM THE BEDSIDE USING THE POSITION BUTTON. DURING THIS PROCESS, THE ARM HIT ITSELF AS THE ASSISTANT MOVED IT RECKLESSLY, CAUSING THE ARM TO BECOME INOPERATIVE AND THE BEDSIDE CONTROL COULD NOT BE USED. THE ISSUE PERSISTED EVEN AFTER RESTARTING THE ARM THREE TIMES. A FIFTH BACK UP ARM WAS USED TO PROCEED WITH THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303522 HUGO¿ RAS SYSTEM MODULAR ELECTROMECHANICAL SURGICAL SYSTEM SCV SURGICAL MRASC0002 10884521826632

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown