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

Model Number	MRASI0005
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	05/12/2026
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, during a robotic laparoscopic prostatectomy while performing bladder-urethral anastomosis, the bipolar maryland forceps (bmf) had damage on its white plastic tip, leading is to become uncontrollable.The bmf was removed using the broken instrument procedure and, in the process, the patient's port site was slightly damaged.This tissue damage is not permanent.Once the bmf was removed, the arm was rolled out with the instrument, and the procedure was completed with three arms.There was a roughly 30 minute delay due to the issue.

• Brand Name: HUGO TM RAS
• 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 55112-4391 ; 8006464633
• MDR Report Key: 25341021
• Report Number: 1219930-2026-03426
• Device Sequence Number: 11210865
• Product Code: SCV
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K250725
• Number of Events Summarized: 1
• Summary Report (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): 05/29/2026

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: MRASI0005
• Device Catalogue Number: MRASI0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 05/31/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MRASI0005 SN: (B)(6).
• Patient Sex: Male