MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; SURGEON SIDE CONSOLE, RECERTIFIED

Model Number	380689-03
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer contacted intuitive surgical, inc.(isi) technical service engineer (tse) and reported the surgeon side console (ssc) right side had no image.Site informed that the vision side cart (vsc) showed both left and right image.Tse reviewed live logs but did not find any related error regarding the issue.The customer hard power cycled but the issue was not resolved.Site was continuing surgery using 2d vision.Isi field service engineer (fse) was dispatched to site to further troubleshoot.The procedure was completing as planned with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the type of da vinci-assisted surgical procedure was performed by the surgeon was robotic abdominoperineal resection (apr).The procedure took place at 10:00 am.It was completed successfully despite the absence of an image on the right side of the high-resolution stereo viewer (hrsv).Refer to section a for additional information.
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 both of the high-resolution stereo viewers (hrsv).The system was tested and verified as ready for use.Isi did not receive a da vinci product involved with this complaint to perform failure analysis.
Additional Manufacturer Narrative
The high-resolution stereo viewer (hrsv) monitor was returned for failure analysis and the reported issue was replicated.In logs no data was found to indicate that the fault had occurred the field.Upon visual inspection no issues were found that would be related to the reported event.The monitor was installed and tested on the test system.It powered on showing a blank screen.As a result of these findings, failure analysis was able to conclude that an electrical component issue in the monitor was found to be the root cause of the reported failure.The second hrsv monitor was returned for failure analysis, and the reported issue was not replicated or confirmed.In logs no data was found to indicate that the fault had occurred the field.Upon visual inspection, no issues were found that would be related to the reported event.The monitor was installed on our test system.Started up without any errors.The image quality was sharp, no noise, and not tinted.Then 10 power cycles were performed, and the system works normally without any issues.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DAVINCI SI
• Common Device Name: SURGEON SIDE CONSOLE, RECERTIFIED
• 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: 22368490
• Report Number: 2955842-2025-28144
• Device Sequence Number: 19930750
• Product Code: NAY
• UDI-Device Identifier: 00886874110782
• UDI-Public: (01)00886874110782
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 06/11/2025

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: 380689-03
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 74 YR
• Patient Sex: Female
• Patient Weight: 50 KG