MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI SP; SURGEON SIDE CONSOLE

Model Number	380940-40
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
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.Removed and replaced right high-resolution stereo viewer (hrsv) monitor.The system was tested and verified as ready for use.Isi did receive a da vinci product involved with this complaint to perform failure analysis.The hrsv-3 monitor was analyzed and found upon powering up the system, there is no image on the hrsv it is completely black.Successfully replicated the complaint the complaint was confirmed based on the field evaluation/failure analysis, which indicates that the device may have contributed to the customer reported issue.
Event or Problem Description
It was reported that prior to starting a da vinci-assisted surgical procedure, during setup to report that he is not seeing an image in the console right eye.Site power cycled and hard power cycled the console.Technical support engineer (tse) walked caller through an addition power cycle and hard power cycle of the console and the tower.Tse also had caller verify fiber cable connections between tower and console.Caller powered system back on and again, the right eye had no image.Tse then had caller power console up in stand-alone however the console right eye was still not present.Tse suggested hard power cycling the console multiple times.Site converted to another dv system.Field service engineer (fse) to follow up.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer noted ports were not placed prior to the issue being identified.The procedure was completed with another system (xi) and dvstat contacted prior to aborting/converting the procedure.There was no patient injury.

• Brand Name: DA VINCI SP
• Common Device Name: SURGEON SIDE CONSOLE
• 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: 24694534
• Report Number: 2955842-2026-17965
• Device Sequence Number: 10439544
• Product Code: NAY
• UDI-Device Identifier: 00886874114735
• UDI-Public: (01)00886874114735
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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: 380940-40
• Device Catalogue Number: 380940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2020
• 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