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

Model Number	380677-17
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to start- pre anesthesia in a da vinci-assisted surgical procedure, no ports placed, the customer identified multiple non- recoverable error messages/ faults on the system while starting the system.The customer rebooted the system using a hard power cycle and swapped and cleaned the blue fiber cable (bfc) but issue did not resolved.The customer decided to proceed laparoscopically without contacting the technical support engineer (tse).Tse contacted customer after the procedure was completed and asked to perform another power cycle, but the issue persisted.Tse checked system logs and confirmed error message/ fault pointing towards personality module surgeon console (pmsc) of the surgeon side console (ssc).
Additional Manufacturer Narrative
An intuitive field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Based on the field evaluation, the fse replaced personality module surgeon console (pmsc) in the surgeon side console (ssc).The system was tested and verified as ready for use.Intuitive surgical inc., (isi) did not received the product for failure analysis evaluation.

• 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: 50189556
• Report Number: 2955842-2026-35146
• Device Sequence Number: 6110927
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 08/09/2026

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: 380677-17
• Device Catalogue Number: 380677
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2019
• 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: Reuse
• 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: Female