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

Model Number	MRASI0001
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that, intra-operatively to a robotic laparoscopic gynecological procedure as part of a clinical study, the monopolar curved shears (mcs) were not recognized and could not be tele-operated.Due to the instrument being out of the field of view, it could not be fully visualized by the surgeon in his attempts to move it back into the field of view.The surgeon, concerned about the sharp instrument being unseen in the cavity, instructed the bedside assistant to remove the shears.The bedside assistant removed and reintroduced the mcs to resolve the issue.The mcs was difficult to load due to being caught in the drapes.There was a delay of approximately 5 minutes.There was no patient injury.

• Brand Name: HUGO? RAS
• 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 55112-4391 ; 8006464633
• MDR Report Key: 25023894
• Report Number: 1219930-2026-02820
• Device Sequence Number: 13327331
• Product Code: SCV
• UDI-Device Identifier: 10884521739949
• UDI-Public: (01)10884521739949(11)240913(20)12
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/28/2026
• Date Device Manufactured: 09/13/2024
• 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: MRASI0001 SN: (B)(6).
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White