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

Model Number	380940-50
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is in progress to determine the cause of this reported event.Additional information is being gathered to determine the contribution of the device to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the gravity compensation on both surgeon side consoles (ssc) was not functioning as expected.The system was restarted several times, but the problem persisted without any error codes being displayed.Although the surgeons were able to continue working with the system, they expressed a desire to have the issue resolved.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up and obtained the following additional information: according to the technical service engineer, the master tool manipulator was being pulled down by gravity, and the gravity compensation was applied and was drifting.
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 confirmed.Both surgeon side consoles (ssc) master tool manipulators (mtm) were calibrated for gravity compensation.The system was tested and verified as ready for use.
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: 24851015
• Report Number: 2955842-2026-21071
• Device Sequence Number: 8946748
• Product Code: NAY
• UDI-Device Identifier: 00886874114735
• UDI-Public: (01)00886874114735
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K182371
• 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,Followup
• Report Date (Section B): 05/12/2026

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: 380940-50
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2023
• 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