MAUDE Adverse Event Report: Surgical Hugo¿ RAS System; MODULAR ELECTROMECHANICAL SURGICAL SYSTEM

Model Number	MRASI0010
Medical Device Problem Codes	Difficult to Insert (1316); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, prior to a robotic laparoscopic partial nephrectomy procedure, while the patient was in the operating room, during docking and instrument insertion, the secure cadiere forceps would not insert into the trocar and did not move.The team attempted to reconnect the instrument, but ultimately decided to use a new secure cadiere forceps, which worked properly.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.

• 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--439 ; +1(800)646-4633
• MDR Report Key: 50866046
• Report Number: 1219930-2026-05904
• Device Sequence Number: 10690996
• Product Code: SCV
• UDI-Device Identifier: 10884521826748
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: MRASI0010
• Device Catalogue Number: MRASI0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 11/21/2025
• 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
• Patient Sex: Unknown