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	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrected the primary product to vision system.
Event or Problem Description
Refer to h11 for follow-up information.
Event or Problem Description
It was reported that during a da vinci-assisted partial nephrectomy surgical procedure, the customer informed intuitive surgical, inc.(isi) technical support engineer (tse) that the illuminator light was dark.The tse had the customer replace the lamp, but the issue was not resolved.The procedure was completed as planned with no reported injury.
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.The fse replaced the illuminator.The system was tested and verified as ready for use.The complaint was not confirmed based on field evaluation.A return material authorization (rma) has been issued for the return of the illuminator camera.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the product involved with this complaint to perform failure analysis.The camera was analyzed, and the reported problem was not confirmed or replicated.The camera was found to have no issue on the light guide.The quality assurance procedure (qap) was able to recognize all different targets/images.There was no ghosting observed when switching from different targets.The camera head light intensity, brightness or luminance was found in good level.Visual inspection found no issue on the camera light guide.Additionally, the camera head failed focus test on in-house system.The camera head was installed on in-house system with in-house endoscope and passed initialization and calibration test.During the qap process, both the right eye and left eye failed focus test and appeared to have blurry image.Manipulated/pressed the focus button up and down with no change on the blurry images.The camera head focus button was functioning.Also, the distal window of endoscope was found to have droplets/fluid intrusion inside the mirror surface.As a result, the surface contamination/fluid intrusion potentially or most likely caused the blurry image observed during in-house testing.The camera head rubber handle was found to have tears/torn.During button pad inspection, a visual inspection found deformity on both sides of the rubber handle of the housing.The complaint was not confirmed based on failure analysis.The probable root cause of dark light reported could not be determined since the fse was unable to reproduce the issue and the camera light was found acceptable during in-house testing.Issues related to instrument errors or complications using the instrument reported by the user with no underlying product issue may be related to customer-induced problems, including misuse of the product and recognition issues.The probable root cause of failed focus test is attributed to contamination/fluid intrusion found inside the camera lens.The probable root cause of tears in rubber handle is likely attributed to mishandling and/or misuse by the user.
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: 22681456
• Report Number: 2955842-2025-32358
• Device Sequence Number: 9664159
• Product Code: NAY
• UDI-Device Identifier: 00886874110683
• UDI-Public: (01)00886874110683
• 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: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 07/10/2025; 08/07/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/01/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2017
• 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 Sex: Unknown