MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; VISION SIDE SYSTEM

Model Number	380990-16
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
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 image didn't show and system powered off.Tse recommended caller checked power cord and guided caller opened rear door of vsc.Caller stated the rear of vsc was too hot.Tse recommended caller let vsc had good ventilation.System could power on automatically.Procedure could complete as planned.The procedure was completed with no reported injury.Intuitive followed up but was able to attain more additional information.System functionality was checked upon powering the system.System initially powered on with no errors.Illuminator did work in the procedure.Procedure was completed in the original configuration with the same illuminator.The field engineer replaced the illuminator.Please refer to section a for patient demographic information.
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 replaced the illuminator.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.Upon visual inspection, both fans are covered in green dust.Inside of the lamp module has a burnt mark.Installed this unit on the printed circuit assembly test system.The illuminator was powered on in maintenance mode and programmed for hd illuminator.Conducted the vision test and white balance test.Ran 10 power cycles and let the system idle for 30 minutes.The illuminator will be returned to the original equipment manufacturer.
Additional Manufacturer Narrative
Correction: the customer restarted the system and completed the procedure in its original configuration with the same illuminator.The probable root cause could be attributed to communication or lamp ignition issues with the illuminator.The issue was resolved by replacing the defective unit.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DAVINCI SI
• Common Device Name: VISION SIDE SYSTEM
• 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: 23012765
• Report Number: 2955842-2025-37460
• Device Sequence Number: 18651620
• Product Code: NAY
• UDI-Device Identifier: 00886874110874
• UDI-Public: (01)00886874110874
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: 380990-16
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 09/06/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2017
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Weight: 59 KG