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

Model Number	380746-46
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
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.The missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the tower would completely lose power at times when the brake pedal was pressed to unlock it.The customer described the loss of power during brake pedal activation but was unable to provide specific information regarding dates or exact procedures related to the power loss.There was no reported injury.
Additional Manufacturer Narrative
Isi did receive a da vinci common compute controller (ccc) involved with this complaint to perform failure analysis.This ccc unit was installed, successfully programmed and tested on in-house known good system, with no issue and no errors triggered on startup.Performed multiple power cycles with no failure.Light levels were checked and all values were in expected range.This unit was left idle in normal mode for three hours with no issue and no failure.The complaint was confirmed based on system logs, which indicates that the device may have contributed to the customer reported issue.The probable root cause is attributed to a power fluctuation issue at the site causing a software issue with the system.
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: 24934406
• Report Number: 2955842-2026-22253
• Device Sequence Number: 10652350
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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 Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/15/2026
• 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