MAUDE Adverse Event Report: SURGICAL HUGO¿ RAS SYSTEM; MODULAR ELECTROMECHANICAL SURGICAL SYSTEM

Model Number	MRASI0001
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Difficult to Remove (1528); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a robotic laparoscopic prostatectomy procedure; while performing dissection, a high priority alarm occurred on the monopolar curved shears(mcs) connected to sterile interface module(sim).Mcs became disabled and resulted in loss of teleoperation.The mcs was removed from sim using broken instrument procedure, re-attached and reinserted into the patient to continue the procedure and resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
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
Medtronic led an evaluation of the device data logs for the reported monopolar curved shears.Evaluation of the device data logs indicate that an 'instrument over-torque' error code was triggered.The use time of the monopolar curved shears when the error happened was five minutes and use count was one.As an after effect of the error code, it turns the instrument drive unit motors off, so following the broken instrument workflow are the right steps to follow.Evaluation of the monopolar curved shears confirmed the reported condition.The root cause of the observed error in the logs of the monopolar curved shears is understood to be a design issue in the software that controls the monopolar curved shears.The controls software is responsible for calculating and commanding the necessary instrument drive unit motor torques that result in instrument movements.Presently, the controls software does not discharge commanded drive torque quickly enough when opening shears blades.As a result, a subsequent rapid command to close the shears may result in drive torque that exceed design limits.When excessive drive torque is detected, the system is designed to arrest instrument movement and prevent subsequent tele-operation by a user in order to prevent instrument damage.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.
Event or Problem Description
It was reported that during a robotic laparoscopic prostatectomy procedure; while performing dissection, a high priority alarm occurred on the monopolar curved shears (mcs) connected to sterile interface module (sim).The mcs became disabled and resulted in loss of teleoperation.The mcs was removed from sim using the broken instrument procedure, then re-attached and reinserted into the patient to continue the procedure and resolve the issue.There was no patient injury.

• Brand Name: HUGO¿ RAS SYSTEM
• Common Device Name: MODULAR ELECTROMECHANICAL SURGICAL SYSTEM
• Manufacturer (Section D): SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24674707
• Report Number: 1219930-2026-01911
• Device Sequence Number: 15977983
• Product Code: SCV
• UDI-Device Identifier: 10884521826694
• UDI-Public: (01)10884521826694(11)240804(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K250725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MRASI0001
• Device Catalogue Number: MRASI0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MRASA0003 SN: (B)(6).
• Patient Sex: Unknown