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

Model Number	380990-16
Medical Device Problem Code	Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted thyroidectomy surgical procedure, clinical sales representative (csr) contacted technical service engineer (tse) and reported that the camera focus function was not working.The customer stated that after pressing the auto calibration button, the focus targeting did not merge together.Additionally, pressing the camera head focus button did not resolve the issue.The customer swapped to a backup endoscope and performed a system power cycle, but issue persisted.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the procedure was converted to traditional laparoscopic surgery.The port incisions were not increased, nor were any additional ports placed.The patient tolerated the conversion without any injury.
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 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
Intuitive surgical, inc.(isi) has received the camera head associated with this complaint and completed investigations the camera head failed the focus test on the in-house system.The camera head was installed on the in-house system and passed initialization.During the qap (quality assurance procedure) process, both 2d left and right eye failed focus test and the image appeared significantly blurry.Pressing the focus button (up and down button) did not show improvement/changes on the blurry image.Additionally, the camera head was found to have button functionality failure.The camera head focus button was not responding.The camera head was installed onto the system with in-house endoscope and had no issue on the illuminator.The camera head¿s focus button was not responding when manipulated.Blurry images were observed during the qap (quality assurance procedure) process.Additionally, the camera head rubber handle was found to have tears/torn.During the button pad inspection, visual inspection found both rubber handles were lifted from its attachment.
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: 22901580
• Report Number: 2955842-2025-35745
• Device Sequence Number: 8000958
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/12/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2017
• 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: 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