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

Model Number	380723-11
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/10/2026
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.The fse replaced the master tool manipulator (mtm).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 logs, the error 23017 was found indicating the motor did not respond as expected on the left mtm in ssc1, axis 6, confirming the fault occurred in the field.Upon visual inspection, the mtm was installed onto a golden system where the error was triggered indicating fault on the axis 6 replicating the reported event.The mtm was then installed onto a surgical fixture test platform (sftp) where power up was found to be failing on the axis 6.Once testing was completed, axis 6 motor was applied behavioral analysis tested and were verified to be the source of the fault.A second mtm was also analyzed.In logs, the error 23017 was found indicating the motor did not respond as expected on the left mtm in ssc1, axis 6, confirming the fault occurred in the field.Upon visual inspection, the mtm was installed onto a golden system where the error was triggered indicating fault on the axis 6 replicating the reported event.The mtm was then installed onto a surgical fixture test platform (sftp) where power up was found to be failing on the axis 6.Once testing was completed, axis 6 motor was applied behavioral analysis tested and were verified to be the source of the fault.
Event or Problem Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure using an xi system, user informed the technical support engineer (tse) that the system were faulting out.The tse reviewed the system logs and identified an issue with the left master tool manipulator (mtml) gimbal.The user did not wish to troubleshoot at that time.Later, the issue returned, and the tse noted error 23017 on the mtml.The user attempted to recover the fault without success and decided to convert the case to a traditional laparoscopic approach.No known impact or patient consequence was reported.

• 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: 24771184
• Report Number: 2955842-2026-20325
• Device Sequence Number: 10299047
• Product Code: NAY
• UDI-Device Identifier: 00886874115374
• UDI-Public: (01)00886874115374
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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: 380723-11
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• 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