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

Model Number	MRASI0010
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
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 procedure, at the start of the procedure after dropping the bladder, the secure cadiere forceps (scf) was retracting tissue but was not grasping it.The surgeon used the other hand and a maryland instrument to remove the tissue from the scf, and the instrument was removed using the instrument drive unit (idu) as normal.Additionally, the scf had an instrument error with a red alarm.The scf was then replaced with a new instrument to resolve the issue and the procedure continued.There was a 10-minute delay.There was no patient injury.
Additional Manufacturer Narrative
H3) device evaluation: medtronic led an evaluation of the associated device logs for the reported secure cadiere forceps.The secure cadiere forceps sample was not made available for this incident.Evaluation of the logs indicated that the secure cadiere forceps was connected to a sterile interface module (sim) when an error code for 'instrument usage read write read sequence' was observed.The logs are not able to confirm if a grasping error occurred as this is associated with a hardware issue.Evaluation of the secure cadiere forceps confirmed the reported condition, however, the investigation concluded there were no abnorm alities 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 a connectivity issue between the instrument and sim.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.
Event or Problem Description
It was reported that during a robotic laparoscopic prostatectomy procedure, at the start of the procedure after dropping the bladder, the secure cadiere forceps (scf) was retracting tissue but was not grasping it.The surgeon used the other hand and a maryland instrument to remove the tissue from the scf, and the instrument was removed using the instrument drive unit (idu) as normal.Additionally, the scf had an instrument error with a red alarm.The scf was then replaced with a new instrument to resolve the issue and the procedure continued.There was a 10-minute delay.There was no patient injury.

• 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 ; 8006464633
• MDR Report Key: 24911128
• Report Number: 1219930-2026-02548
• Device Sequence Number: 9800003
• Product Code: SCV
• UDI-Device Identifier: 10884521826748
• UDI-Public: (01)10884521826748(11)250730(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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2026

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 05/20/2026; 08/09/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 06/11/2026; 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown