MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC daVinci Xi; SURGEON SIDE CONSOLE, SMART PEDALS

Model Number	380677-31R
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to starting a da vinci-assisted surgical procedure using an xi system, and after surgical port placement, an intuitive surgical, inc.(isi) field service engineer (fse) called from offsite to report error 903 occurred.The technical support engineer (tse) reviewed the logs and found error 25514 for remote arm controller (rac) 2.The site performed a couple of power cycles, but the error persisted.The procedure was converted to another dv system, and no patient injury was reported.
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Fse was able to reproduce the error issue with remote arm controller (rac) and replaced it to correct the reported problem.System was tested and verified as ready for use.The complaint was confirmed based on the field evaluation.Isi has not received the product associated with this event to perform failure analysis.Therefore, the root cause of the customer reported failure mode has not been determined.

• Brand Name: daVinci Xi
• Common Device Name: SURGEON SIDE CONSOLE, SMART PEDALS
• 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 ; +1(408)523-2100
• MDR Report Key: 50215568
• Report Number: 2955842-2026-35261
• Device Sequence Number: 17669940
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: 380677-31R
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/01/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2025
• 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