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	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to start of a da vinci-assisted surgical procedure, the customer contacted the technical support engineer (tse) and reported they experienced multiple non-recoverable faults on the system, specifically faults 170, 40068, and 307.The tse instructed the customer to perform a hard power cycle on all system components, but the faults continued to recur after the reboot.The system was unable to provide logs for further analysis.The procedure was aborted with no patient involvement.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the procedure was aborted.There was no patient involvement.
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 patient side cart (psc) card cage and vision side cart (vsc)common computer controller (ccc) to correct the issue.The system was tested and verified as ready for use.Isi did receive the product involved with this complaint to perform failure analysis; however, failure analysis has not completed their investigation.
Additional Manufacturer Narrative
The patient side cart (psc) card cage and vision side cart (vsc) ccc has been returned and evaluated by the failure analysis (fa) team.This psc cardcage was returned for failure analysis due to reported errors 170, 40068, and 307.These errors were confirmed in lighthouse system logs and successfully reproduced during testing.The visual inspection of the psc cardcage revealed no defects related to the reported issue.Two units: the cardcage-psc and the ccc vsc were returned together and tested in an in-house golden system.The system was programmed and initially started without issue.However, after approximately one hour of operation, errors 31089, 170, and 307 were triggered.An aba procedure was performed on the optic fiber cable at the ff3 location in the ccc on cardcage using the golden system: 1.A good-known optic fiber cable was installed at the ff3 location in the ccc on cardcage.The system started without issue.Power cycling was performed, and optic light levels were verified to be within the expected range.The system then ran in normal mode for two hours with no errors or abnormalities observed.2.The original optic fiber cable was reinstalled at the ff3 location in the ccc on cardcage.Errors 31089, 170, and 307 reappeared.The aba swap test confirmed that the optic fiber cable at ff3 in the ccc on cardcage is the source of the issue.Based on these findings, the root cause of the reported event was determined to be a faulty firefly fiber optic cable (ff3) in the ccc on cardcage-psc.This ccc vsc was returned for failure analysis due to reported errors 170, 40068, and 307.These errors were confirmed in lighthouse system logs and successfully reproduced during testing.The visual inspection of the ccc vsc revealed no defects related to the reported issue.The system was programmed and initially started without issue.However, after approximately one hour of operation, errors 31089, 170, and 307 were triggered.An aba procedure was performed on the optic fiber cable at the ff3 location on the ccc cardcage using the golden system: 1.A good-known optic fiber cable fiber cable was installed at the ff3 location on the ccc cardcage.The system started without issue.Power cycling was performed, and optic light levels were verified to be within the expected range.The system then ran in normal mode for two hours with no errors or abnormalities observed.2.The original optic fiber cable was reinstalled at the ff3 location on the ccc cardcage.Errors 31089, 170, and 307 reappeared.The aba swap test confirmed that the optic fiber cable at ff3 on the ccc cardcage is the source of the issue.Based on these findings, the root cause of the reported event was determined to be a faulty firefly fiber optic cable (ff3) in the ccc cardcage psc.No fault was found with this ccc vsc, and it is a non-defective (incorrect) return.
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: 24961866
• Report Number: 2955842-2026-22619
• Device Sequence Number: 4992259
• Product Code: NAY
• UDI-Device Identifier: 00886874119662
• UDI-Public: (01)00886874119662
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,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 Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2025
• 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