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

Model Number	380677-27
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during da vinci-assisted surgical procedure, site contacted intuitive technical support engineer (tse) to report a fault.Caller stated that usm#1 was out of control.After power cycle system, issue disappeared and the procedure was completing as planned.System did not show any errors.The procedure was completed with no reported injury.Intuitive followed up and obtained additional information.Usm did not move with unintuitive motion.Surgeon found that mtml grip could not control the instrument on the usm 1.The issue did occur with the surgeon¿s head inside the surgeon console¿s high resolution stereo viewer.The issue did occur while the surgeon was attempting to manipulate instruments from the surgeon console.The movements of the surgeon scale appropriately to the universal surgical manipulator (usm).The usm did not move in the intended direction (intended direction right and observed instrument movement right).The timing of the usm movement was appropriate.There was no shakiness.There was no system arm-to-arm interference.There was no patient injury.
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 was not able to reproduce the reported problem.The fse reviewed the log and identified errors pointing to a faulty left master tool manipulator (mtm).The fse replaced the 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.However, failure analysis is not complete.

• 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: 50900298
• Report Number: 2955842-2026-39836
• Device Sequence Number: 6001746
• Product Code: NAY
• UDI-Device Identifier: 00886874110744
• UDI-Public: (01)00886874110744
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/25/2026

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: 380677-27
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2023
• 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