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	04/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to starting a da vinci-assisted surgical procedure, the system displayed error 319.The error was confirmed in the system logs.Technical support then guided the user to remove the hdmi cables and usb from the video integration platform and perform a hard power cycle of the tower, but this did not resolve the issue.The user then proceeded with the case using a different system.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Based on the field evaluation, this reported event was confirmed.Fse was able to replicate the reported issue.Fse replaced vip to resolve the issue.The system was tested and verified as ready for use.An rma was issued to the customer requesting to have the intuitive surgical, inc.(isi) device returned.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Additional Manufacturer Narrative
This vision side cart (vsc) vip assembly was returned for failure analysis.The reported error 319 was confirmed and successfully replicated.In logs, error 319 indicates that a node was not present at startup, confirming that the fault occurred in the field.Visual inspection found no issues related to the reported event.The unit was installed, successfully programmed, and tested on the in-house dv5 golden system, where error 319 was triggered at startup, replicating the reported event.A test was performed by replacing the fiber optic firefly cable assembly; however, the issue persisted.Based on these tests and findings, failure analysis concluded that the potential root cause may be the vsc vip cfg board in this vsc vip assembly, which is associated with the reported error.
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: 24946577
• Report Number: 2955842-2026-22298
• Device Sequence Number: 10093210
• Product Code: NAY
• UDI-Device Identifier: 00886874119662
• UDI-Public: (01)00886874119662
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: 04/16/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2025
• 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