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

Model Number	380940-33
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure the system the surgeon was not able to activate finger clutch of the master tool manipulator (mtmr).There is message "hand control switches been disabled by system".Explained to customer that surgeon is able to use foot pedal clutch.Advised customer to verify that finger clutch is working fine after power cycle of system.The procedure continued robotically.
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Based on the field evaluation, this reported event was not confirmed.The fse proactively replaced mtmr and rac2 as a preventive measure.The master tool manipulator was received for failure analysis.The issue was confirmed in the logs, however it could not be replicated during testing.No visual defects related to the reported issue were identified during inspection.The configured (cfg) remote arm controller (rac) was received for failure analysis.The complaint was confirmed but not replicated.In the logs, the errors were located, indicating that the error occurred in the field.Confirming the reported event.Visual inspection, no damage was observed on the exterior and interior of the unit.No issues were found related to the reported issue.The rac was installed in the inhouse system where it functioned as expected.All nodes were present.The inhouse system was set to run 10 power cycles and sat idle for one hour.The mtm was driven manually, the rac functioned as expected.Once testing was complete, the system error logs were investigated but no error related to the reported event could not be found.Mfr report number 2955842-2026-23544 will address the procedure completed by converting to open surgery.

• 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: 25090297
• Report Number: 2955842-2026-23543
• Device Sequence Number: 15950079
• Product Code: NAY
• UDI-Device Identifier: 00886874114735
• UDI-Public: (01)00886874114735
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 05/05/2026

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: 380940-33
• Device Catalogue Number: 380940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2019
• 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: Unknown