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

Model Number	380940-51
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/04/2026
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 not receive a da vinci product involved with this complaint to perform failure analysis.
Event or Problem Description
It was reported that prior to start of a da vinci-assisted surgical procedure that recoverable error 23013 occurred against the left master tool manipulator (mtm).The ports had not been placed in the patient when the issue occurred.The intuitive tech support engineer (tse) reviewed the system logs and found several 23013 and 23008 errors against axis 1 of the left mtm.The tse instructed the caller to reboot the system using the emergency power off function.The issue persisted and it was not possible to recover the fault.The surgeon decided to abort the procedure to a different system.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.Failure analysis investigations did confirm and replicate the customer complaint "error 23013".Errors 23013, 23008 were confirmed in the logs and replicated on the surgical fixture test platform (sftp).No visual failures related to the reported problem were found during inspection.Functional testing on an sftp system resulted in failing axis 1 motor.An applied behavioral analysis swap was performed on axis 1 motor and confirmed it as the root cause of the reported event.To rectify the unit failure, the axis 1 motor assembly will be replaced.The probable root cause is attributed to an electrical/fiberoptic defect pertaining to the axis 1 motor of the mtm.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DA VINCI SP
• Common Device Name: SURGEON SIDE CONSOLE
• 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: 24707148
• Report Number: 2955842-2026-18953
• Device Sequence Number: 10463019
• Product Code: NAY
• UDI-Device Identifier: 00886874114735
• UDI-Public: (01)00886874114735
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 380940-51
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2024
• 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