MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI SP; SURGEON SIDE CONSOLE

Model Number	380940-55
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted radical prostatectomy w/o lymphadenectomy surgical procedure, the surgeon lost function of the endoscope however maintained video, but the surgeon was not able to move the camera at all.The customer power cycled the system with no change and was in the process of performing a hard reboot on the system when the call started.The system rebooted and the surgeon was not able to take control of any of the arms and noted that the foot pedals were also non-responsive.The customer confirmed no error messages, no flashing arm leds, and the surgeon's head was fully in the viewer.Technical support engineer (tse) was unable to view system logs during the call.Tse recommended replacing the drape.At that time, the customer advised that everything started working normally.Tse remained on the line until the customer was comfortable proceeding.The procedure was completing as planned with no reported injury.
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Fse conducted troubleshooting with technical support engineer (tse) and product support due to error 31061.They advised replacing the foot pedals.The doctor reported that swap pedal and camera pedal weren't responding but energy was.Fse replaced the footrest to resolve the issue.The system was tested and verified as ready for use.Isi did receive a da vinci product involved with this complaint to perform failure analysis.The footrest was returned for failure analysis, and the reported failure was replicated.In system logs, error 31061 was found indicating that the fault had occurred in the field.Upon visual inspection, no issues were identified that could be related to the reported event.The unit was then installed onto the golden system along with the instruments to test the functionality of the pedals.Initially, the camera was not responding right away; some delays were observed.However, after leaving it idle for around 15 minutes, both the camera pedal and clutch pedal completely stopped responding, and the issue was successfully replicated.The complaint was confirmed based on failure analysis.The camera and clutch pedals were determined to be the root cause of the reported event.

• Brand Name: DA VINCI SP
• Common Device Name: SURGEON SIDE CONSOLE
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 24780218
• Report Number: 2955842-2026-20372
• Device Sequence Number: 13270958
• Product Code: NAY
• UDI-Device Identifier: 00886874114735
• UDI-Public: (01)00886874114735
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• 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: 380940-55
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/24/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Male