MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI XI; SURGEON SIDE CONSOLE, RECONDITIONED

Model Number	380723-12
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to starting a da vinci-assisted surgical procedure, the system faulted at the end of the first procedure of the day when moving the patient side cart (psc) away from the bed.Technical support engineer (tse) had customer perform hard power cycle and verify blue fiber cable connections, but system kept powering on with error 23.Tse log review showed errors reporting from the left master tool manipulator (mtml) armnet.Customer will be moving procedure to other davinci system on site.The procedure was aborted to another dv system with patient involvement.
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.Fse swapped out the right master tool manipulator (mtmr) and mtml in january for the same fault.Error 23 was on mtml, and the fault occurred again on the same armnet.The remote arm controller (rac1) was replaced.The error was never reproduced before replacement but was confirmed in the logs.Fse test drove system after replacement did not produce any error codes.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.The rac1 was returned for failure analysis, and the reported error was confirmed but could not be reproduced.In system logs, error 23 was found indicating the fault, confirming it occurred in the field.A visual inspection revealed no issues related to the reported issue.The unit was installed onto the golden system and completed program with no problem.Continued performance was set to 10 power cycles and sat idle for one hour.After testing, the system error logs were inspected, but no error could be identified.The rac was sent to vendor to be reprogrammed and completed verification test.The complaint was confirmed based on field evaluation.

• Brand Name: DA VINCI XI
• Common Device Name: SURGEON SIDE CONSOLE, 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: 24866675
• Report Number: 2955842-2026-21340
• Device Sequence Number: 10476196
• Product Code: NAY
• UDI-Device Identifier: 00886874115374
• UDI-Public: (01)00886874115374
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2026

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: 380723-12
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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