MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI XI; VISION SIDE SYSTEM, RECONDITIONED

Model Number	380721-11
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
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.Based on the field evaluation, this reported event was confirmed.Fse replaced the advanced video processor (avp).The system was tested and verified as ready for use.Isi did receive a da vinci product involved with this complaint to perform failure analysis.In the system logs, errors 40068 and 310 were found.Upon visual inspection, no issues were found that would be related to the reported failure.The avp was installed and tested into a golden printed circuit assembly (pca) system where the component functioned as expected.The system was programmed and started up without any error, onsite connection is present and data was uploaded.20 power cycles were ran with this board, which all passed.The avp remained on the test system in normal operation for hours, but it performed without any errors.The reported issue was confirmed via the error logs, but was unable to be replicated by failure analysis, which indicates that the device may have contributed to the customer reported issue.
Event or Problem Description
It was reported that after a da vinci-assisted surgical procedure, all system arms turned on with red led lights when shutting down the system and error code 40068 was displayed.The technical support engineer (tse) guided the caller to perform a hard power cycle, but the issue did not resolve.Error 40068 occurred every time the system shut down.The system was not connected to onsite.The tse confirmed with the caller that the ethernet cable was correctly connected on both sides, which was the case.The tse guided the caller to check if onsite indications were present on the vision side cart (vsc) settings, which was not the case.The procedure was completing as planned with no reported injury.

• Brand Name: DA VINCI XI
• Common Device Name: VISION SIDE SYSTEM, RECONDITIONED
• 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: 24710101
• Report Number: 2955842-2026-19232
• Device Sequence Number: 6012949
• Product Code: NAY
• UDI-Device Identifier: 00886874115343
• UDI-Public: (01)00886874115343
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: 380721-11
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2022
• 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