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	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci assisted surgical procedure, the customer contacted the technical support engineer (tse) and reported that errors 170 and 31089 were occurring.A new blue fiber cable had been opened, a power cycle had been performed, and the blue fiber cable had been reconnected prior to contacting support.At the time of the call, ports had been placed but the system had not yet been docked.Upon power up, neither blue cable port on the back of the vision side cart (vsc) displayed blue leds.Due to a patient being on the table, the decision was made to bring in a different vision cart rather than continue swapping cables.The replacement vision cart was connected and the system powered on without errors for approximately three minutes before faulting again with the same 31089 errors.The backup blue fiber cable was then attempted, but the errors returned.A replacement patient side cart (psc) was subsequently obtained and connected alongside the replacement vision cart, while the original surgeon side console (ssc)remained connected.The system was considered down.The procedure was converted to another dv system.
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 replaced the vision side cart (vsc) common compute controller (ccc), patient side cart (psc) ccc and internal psc fiber cable to correct the issue.The system was tested and verified as ready for use.Isi did receive the product involved with this complaint and performed the failure analysis.The psc ccc cfg was returned for failure analysis, and the reported errors 170, and 31089 were confirmed but not replicated.In artemis, these errors were found indicating communication errors.Also confirming that this fault did occur in the field.Upon visual inspection, no issues were found that would be related to the reported event.This psc ccc cfg was installed, successfully programmed and tested on the dv5 in house golden system with no issue and no errors triggered at startup, system started at normal as expected.Run 5x power cycles with no failures and no errors triggered.This unit was idling for 1.5 hours in normal mode, with no issues and no errors triggered.Check on the light level, all channels are well within normal range.As a result of this test and findings, failure analysis concluded that no root cause could be attributed to this psc ccc cfg unit to the reported failure.The vsc ccc was returned for failure analysis, and the reported problem were confirmed and replicated.In the lighthouse review log, error 31089 was noted on the msc node which were pointing to ff3.This confirms that the fault had previously occurred in the field.Visual inspection, no issue was found that would be related to the reported event.The vsc ccc was installed on a golden system, where the component functioned as expected.The fiber optic light levels on the ccc were inspected, and all values were within the expected range.The system then completed 10 power cycles, followed by an idle period of more than 4 hours on the golden system.However, after approximately 4 hours of idling, the system intermittently reported error 307.This error indicated that a present node which was previously observed by the system stopped responding/disappeared after started up.Failure analysis continued power cycling the system multiple times.However, error 307 continued to occur intermittently.The investigation then focused on the firefly cables as a potential cause.The light level reading for firefly cable ff4 was found to be lower than expected.An aba swap was performed by replacing the ff4 with a known good cable.Following the swap, the ff4 light level reading increased to the expected range, confirming normal operation.This result indicates that the original ff4 firefly cable was the likely cause of the intermittent error 307.As a result of these findings, failure analysis was able to conclude that ff4 was the root cause of the reported event.

• 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 ; +1(408)523-2100
• MDR Report Key: 50910824
• Report Number: 2955842-2026-40143
• Device Sequence Number: 5776835
• Product Code: NAY
• UDI-Device Identifier: 00886874119662
• UDI-Public: (01)00886874119662
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2026

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?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2025
• 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: Unknown