inforMED
MalfunctionSCV

Hugo¿ RAS System

Received Jul 28, 2026 · Event occurred Jul 9, 2026

Report 1219930-2026-04674 · MDR key 50054042

Device

Generic name

Modular Electromechanical Surgical System

Manufacturer

Surgical

Model number

MRASC0002

Catalog number

MRASC0002

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, during docking, while the patient is in the operating room, the arm triggered a non-recoverable error. The surgery 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.