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

Model Number	380990-16
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
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 able to reproduce the reported complaint and replaced the illuminator.The system was tested and verified as ready for use.Isi did receive the illuminator involved with this complaint to perform failure analysis (fa).Fa was able to confirm the reported complaint via the system logs but could not reproduce the issue during in-house testing.The illuminator lamp failed to ignite.Upon visual inspection there were 5 screws missing on the cover.Inside of the lamp module housing had a burnt mark.Fa installed this unit on a testing si system, the unit powered on in maintenance mode and programmed for hd illuminator.The vision test and white balance test were conducted.The system ran 10 power cycles and was left idle for 30 minutes.And the reported complaint was not replicated.While a definitive root-cause cannot be established, the potential root cause for this failure can be attributed to an issue with a component within the illuminator.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the user informed an intuitive surgical, inc.(isi) technical support engineer (tse) that the lamp failed to ignite.Initially, a reboot of the system was attempted, which resulted in the lamp turning on; however, the intensity was found to be insufficient.The user converted to a laparoscopic approach to continue with the procedure.A procedure delay of 15 minutes was reported.Isi followed up with the initial reporter and obtained additional information: the reporter confirmed that no additional port incisions were made, or additional ports placed when the procedure was converted to traditional laparoscopic surgery.Additionally, it was stated that the patient tolerated the change well.

• 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: 23068783
• Report Number: 2955842-2025-37984
• Device Sequence Number: 9866600
• 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,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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: 09/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 09/16/2025
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 54 KG