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

Model Number	MRASI0010
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
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 at the start of a robotic laparoscopic prostatectomy procedure, while connecting the secure cadiere forceps instrument to the arm, the system did not recognize the instrument and the sterile interface module (sim).The instrument was replaced with another secure cadiere forceps to resolve the issue.There was no patient injury.
Event or Problem Description
It was reported that at the start of a robotic laparoscopic prostatectomy procedure, while connecting the secure cadiere forceps ins trument to the arm, the system did not recognize the instrument and the sterile interface module (sim).The instrument was replaced with another secure cadiere forceps to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
H3) device evaluation: medtronic led an evaluation of the reported secure cadiere forceps and the associated device logs.Evaluation of the logs showed that the secure cadiere forceps was connected to a sterile interface module (sim).There were instances of a manual insertion attempt without an instrument being connected.This can indicate connectivity issues.The secure cadiere forceps was replaced with another one.Visual inspection of the returned secure cadiere forceps noted no corrosion on the electrical contacts.There was no damage noted to the jaws or of the drive cables.Functionally, the jaws were manipulated into multiple positions in order to inspect the cables.The jaws were able to achieve each position fully with no difficulty.Electrical testing was performed and the secure cadiere forceps was read with no observed failures.Evaluation of the secure cadiere forceps confirmed the reported condition, however, the investigation concluded there were no abnor malities 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 instrument connectivity issues.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 55112-4391 ; 8006464633
• MDR Report Key: 24343508
• Report Number: 1219930-2026-00932
• Device Sequence Number: 9673934
• Product Code: SCV
• UDI-Device Identifier: 10884521826748
• UDI-Public: (01)10884521826748(11)250925(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 04/03/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MRASA0003 SN: UNKNOWN.
• Patient Sex: Unknown