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

Model Number	MRASI0004
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a robotic-assisted liver resection laparoscopic procedure, during initial instrument attachment after do cking, the bipolar fenestrated grasper (bfg) displayed a message indicating that it could not be recognized by the arm or sterile interface module (sim), and insertion was disabled.Undocking, unbraking the cart, redocking, and retrying insertion did not resolve the issue.A different instrument was then attached to confirm functionality of the arm and sim, and that instrument inserted successfully.The bfg was replaced with another instrument, and the case proceeded.There was no injury to the patient.
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): Covidien Surgical; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): Covidien 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: 50671281
• Report Number: 1219930-2026-05571
• Device Sequence Number: 18459756
• Product Code: SCV
• UDI-Device Identifier: 10884521850958
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K250725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: MRASI0004
• Device Catalogue Number: MRASI0004
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 03/23/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 174 LB