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

Model Number	380940-33
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Fse replaced the surgeon side console (ssc), vision side cart (vsc), and patient side cart (psc) due to multiple reported issues on the systems.The system was tested and verified as ready for use.Isi has not received the ssc, vsc, psc or for evaluation.A follow-up mdr will be submitted, if additional information is obtained.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the were multiple reported issues on the surgeon side console (ssc), vision side cart (vsc), and patient side cart (psc).No known impact or patient consequence was reported.Follow-up with field service engineer (fse) via phone and provided additional information regarding the complaint: the fse reported this site has had multiple system events captured under individual work orders.The fse stated there was no procedure conversion from single port to multi port on the reported event date of 02/09/2026.The fse was referring to a past event on 01/21/2026 captured under pr (b)(4).
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product involved with this complaint to perform failure analysis.The surgeon side console (ssc), vision side cart (vsc), and patient side cart (psc) were all returned for failure analysis for customer satisfaction after a series of persistent system complaints.After reviewing system logs, it was found that no errors were present that would be related to the prior complaints.All data showed that the systems were functioning as designed at the time of systems replacements.All carts returned as part of this complaint were assembled and tested together.During visual inspection, no issues were identified that would be related to prior complaints.The systems were powered on in normal mode without triggering any faults or errors.The systems were driven and power cycled 30 times without triggering any faults or errors.All joints were actuated, all buttons and switches were exercised, and the systems functioned as designed.Testing was also performed on both ssc¿s master tool manipulators (mtm), and the psc¿s column, shoulder, boom, and entry guide manipulator (egm) axis, and was able to pass all testing.The complaint was not confirmed based on failure analysis.
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: 24552332
• Report Number: 2955842-2026-15525
• Device Sequence Number: 13096244
• Product Code: NAY
• UDI-Device Identifier: 00886874114735
• UDI-Public: (01)00886874114735
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2019
• 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: 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