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

Model Number	MRASI0010
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a robotic-assisted radical prostatectomy laparoscopic procedure, while using the fourth arm for traction of the dorsal venous complex (dvc) and bladder neck, the secure cadiere forceps (scf) did not grip tissue properly and tore tissue during traction.Additional sutures and another instrument were used to complete the traction.The surgery time was extended by more than 30 minutes.
Additional Manufacturer Narrative
H3 and h6: annex b, annex c, annex f and annex g have been updated.Device evaluation: medtronic led an evaluation of the associated device data for the reported secure cadiere forceps (scf).Evaluation of the device data indicate occurrence of an error code ¿ra_j5 redundancy check¿, with one of the reference switches on the z-slide being triggered while exceeding the expected position range.Evaluation of the device data for the reported secure cadiere forceps confirmed the reported condition.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition; therefore, the investigation was not able to identify a root cause.However, the most likely cause could be traced to robotic arm joint 5 position issue.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality release specifications at the time of manufacture.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): 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--439 ; +1(800)646-4633
• MDR Report Key: 50104802
• Report Number: 1219930-2026-04783
• Device Sequence Number: 18654760
• Product Code: SCV
• UDI-Device Identifier: 10884521826748
• UDI-Public: (01)10884521826748(11)251121(20)02
• 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,User Facility
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

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: MRASI0010
• Device Catalogue Number: MRASI0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2025
• 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
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 209 LB