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

Model Number	380990-16
Medical Device Problem Code	Optical Distortion (3000)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during da vinci-assisted prostectomy surgical procedure, site contacted technical support engineer (tse) to report camera could not focus while performing calibration.Site power cycled the system with circuit breaker reset, but issue persisted.Tse guided site to tighten camera cable, reseat scope, try use grip to adjust focus, but issue did not resolve.The procedure was converted to another dv system with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the system functionality was checked upon powering on the system and the system initially powered on without errors.The reported issue was not resolved then the procedure was converted to another dv system.
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 camera head to resolve the issue.The system was verified and ready to use.Isi has not received the camera head for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
Additional Manufacturer Narrative
The camera head was analyzed, and the reported problem was confirmed and replicated.The primary finding of a failed functional focus test was determined to be related to the customer¿s reported complaint.The camera head passed initialization on an in-house system but failed the quality assurance procedure (qap) focus test for both the left and right 2d eyes, with the image appearing significantly blurry.Adjusting the focus button (up and down) did not resolve the issue.Additionally, the camera head exhibited button functionality failure, as the focus button was nonresponsive.Installed with an in-house endoscope, the camera head showed no issues with the illuminator; however, the focus button remained unresponsive, and blurry images persisted during qap testing.In addition, the camera button pack was found torn, with deformity observed on one side of the rubber pad and the rubber handle of the camera head was also torn, with both rubber grips missing from the housing.The complaint was confirmed and replicated by failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause of the failed functional focus test is attributed to damage during use or improper handling.Damage can result from mechanical impact, such as accidental drops of the endoscope or inadvertent collisions with hard surfaces.The probable root cause of the button functionality failure is attributed to an electrical issue with the button.The probable root cause of the torn button pack and torn rubber handle is attributed to mechanical damage during use or improper handling, which may include accidental drops of the endoscope.In some cases, extensive cracking leading to the button pack breaking off can occur, which is likely caused by improper cleaning during reprocessing.
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: 22931341
• Report Number: 2955842-2025-36477
• Device Sequence Number: 10354466
• 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,Followup
• Report Date (Section B): 08/13/2025

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: 08/13/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2016
• 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: Male