MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI 5; VISION SIDE CART

Model Number	380746-46
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The probable root cause is attributed to a power fluctuation issue at the site causing a software issue with the system.This issue can be resolved by fse service to reprogram the system.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse arrived on site to find the tower was unresponsive.The fse asked the staff whether there had been a power outage in the room or any generator testing, as the symptoms observed were consistent with possible power fluctuation issues.The staff stated there had been generator testing, though this had not been officially confirmed.The fse recommended considering the use of a ups system for the robot to ensure clean, stable power and reduce the risk of similar events.The fse powered the system on in maintenance mode.The fse reviewed the system logs and identified error 40096.The system tower would boot, but the displays showed no image.The fse reprogrammed the system; after reboot, the system powered on normally with full display functionality.The fse removed the front drawers to inspect internal linkage for potential wiring damage, but there were no issues found.The fse performed 10 consecutive power cycles, testing the brake system between each cycle with no faults observed.The fse later returned and verified that the system was unresponsive upon arrival.The fse powered the system into maintenance mode and reprogrammed the system to remove it from the golden image state.The fse inspected the tower power cable and core power cable and found no issues.The fse replaced and reprogrammed the common compute controller (ccc).The fse relocated the system power connection to a different wall receptacle.The system was tested and verified as ready for use.
Event or Problem Description
It was reported that prior to starting a da vinci-assisted surgical procedure, errors 311 and 40096 were encountered at power up.The caller informed the system was down.The caller reported that all the led's were yellow.Prior to calling, the customer tried restarting the system multiple times with no resolve.The technical support engineer (tse) noted an error 311 in the system events logs.The customer had cancelled the case.The tse noted that the system would most likely require reprograming to correct the issue along with a possible common compute controller (ccc) replacement.The procedure was aborted prior to patient involvement.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: the staff attempted to use the handheld camera and pressed the pedals to unlock the tower for repositioning.At that moment, the system shut off unexpectedly.
Additional Manufacturer Narrative
The common compute controller (ccc) was returned for failure analysis for errors 311 and 40096.The reported issue was confirmed, but could not be replicated.The unit was visually inspected and observed to be returned in good physical condition.Failure analysis reviewed the error logs and confirmed errors 311 and 40096 triggered in the field.The ccc unit was installed, successfully programmed, and tested on an in-house golden da vinci 5 system with no issues and no errors triggered on startup.Failure analysis performed multiple power cycles with no failure.The light lever had been checked and all values were in expected range.The ccc unit was idling in normal mode for 3 hours with no issues and no failure.From these findings, failure analysis concluded that no root cause could be attributed to the ccc unit.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DAVINCI 5
• Common Device Name: VISION SIDE CART
• 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: 24932740
• Report Number: 2955842-2026-22158
• Device Sequence Number: 10652274
• Product Code: NAY
• UDI-Device Identifier: 00886874119662
• UDI-Public: (01)00886874119662
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K232610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2026

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: 380746-46
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/26/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 05/06/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 04/21/2026; 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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: Unknown