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

Model Number	MRASI0001
Medical Device Problem Codes	Break (1069); Device Fell (4014)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a robotic laparoscopic radical prostatectomy procedure, the tip of the monopolar curved shears (mcs) br oke off and fell into the patient¿s cavity.The team searched for the broken part using a magnet.An x-ray was not used because the team believed there was a high probability that the part had been removed by the suction device.The instrument was replaced with a new one.
Additional Manufacturer Narrative
B1: adverse event & product problem preliminary device evaluation: medtronic is leading an evaluation of the reported monopolar curved shears (mcs).Review of the three provided images notes the first image shows the mcs with a missing tip on one of the instrument jaws.The second image shows the serial number of the instrument, which matches the reported information.The third image shows a lateral view of the mcs with the tip of one side of the jaw missing.Further evaluation of the reported monopolar curved shears is still pending, and the investigation is not able to identify a root cause at this time.Additional information will be provided in a supplemental regulatory report when the investigation is complete.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): 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--439 ; +1(800)646-4633
• MDR Report Key: 50062871
• Report Number: 1219930-2026-04689
• Device Sequence Number: 21112006
• Product Code: SCV
• UDI-Device Identifier: 10884521826694
• UDI-Public: (01)10884521826694(11)260601(20)13
• 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): 09/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MRASI0001
• Device Catalogue Number: MRASI0001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown