Hugo¿ RAS System
Received Jul 28, 2026 · Event occurred Jul 9, 2026
Report 1219930-2026-04673 · MDR key 50054006
Device
Product problems
- Display or Visual Feedback Problem
- Communication or Transmission Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that, prior to a robotic laparoscopic low anterior resection surgery, while the patient is in the operating room and when the team attempting to manually move the arm by pressing the fulcrum button, the arm triggered an error. The arm was docked but remained frozen. As a result, the robotic procedure was converted to laparoscopy. 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.