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

Model Number	MRASI0006
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
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, the monopolar curved shears (mcs) were not performing like it should during bladder takedown, specifically with cold cutting.The physician was not satisfied with the performance of the mcs.The mcs were swapped with another mcs which was satisfactory to the physician and the surgery continued with very little delay.Additionally, the large needle driver had an out of the box failure.The lnd was not recognized within the sixty second window which caused a yellow instrument error.Instructed bedside assist to detach the instrument, reconnected instrument but same error.After sixty seconds of use, it alarmed once more.The lnd was switched for a new lnd and it was recognized and the surgery continued successfully.There was no issue with the sterile interface module (sim).There was no patient injury.
Additional Manufacturer Narrative
H3 and h6: annex b, annex c and annex g have been updated.Device evaluation: medtronic led an evaluation of the returned large needle driver (lnd) as well as the associated device data.Visual inspection of the returned lnd noted no corrosion on the electrical contacts.There was no damage noted to the jaws of the i nstrument.Microscopic inspection of the drive cables noted no damage.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 instrument was read with no observed failures.Evaluation of the device data indicates the lnd was attached to sterile interface module (sim) sn: (b)(6) and arm cart assembly (aca 4) sn: c25tlk1652.Approximately a minute after the lnd was attached onto the aca, an error code ¿read write sequence fail¿ was triggered and indicates the system was not able to write the updated use count/use time on the instrument after the system recognized it.This error code is a recoverable inoperable error and reports the error message: "caution: instrument error.Detach instrument; clean and dry attachment contact surfaces.If error persists, discard instrument.".Evaluation of the device data for the reported large needle driver confirmed the reported condition, however, 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 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.
Event or Problem Description
It was reported that prior to a robotic laparoscopic prostatectomy, the large needle driver (lnd) had an out of the box failure.The lnd was not recognized within the sixty second window which caused a yellow instrument error.The bedside assistant was instructed to detach the instrument and reconnect it but the lnd had the same error.After sixty seconds of use, it alarmed once more.The lnd was switched for a new lnd and it was recognized and the surgery continued successfully.There was no patient injury.

• Brand Name: HUGO? RAS
• 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 55112-4391 ; 8006464633
• MDR Report Key: 24688966
• Report Number: 1219930-2026-01942
• Device Sequence Number: 21245909
• Product Code: SCV
• UDI-Device Identifier: 10884521850972
• UDI-Public: (01)10884521850972(11)260106(20)15
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: MRASI0006
• Device Catalogue Number: MRASI0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MRASI0001
• Patient Sex: Male