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

Model Number	380940-45
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) has been requested to investigate the reported event.At this time, the fse investigation has not been completed.
Event or Problem Description
It was reported that during a training/demo of the da vinci system there were lines going across the screen in the surgeon side console (ssc) and that this was an ongoing issue.There was no report of patient involvement.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The high resolution stereo viewer (hrsv) was analyzed and found the reported event was replicated.No related errors were found in system logs.Upon visual inspection, no issues were identified that could be related to the reported event.The unit was installed onto a golden system, where it displayed an image with a bundle of vertical lines on the right side of the screen.Isi received the da vinci product to perform failure analysis.The second high resolution stereo viewer (hrsv) was analyzed and the issue was replicated.No related errors were found in system logs.Upon visual inspection, no issues were identified that could be related to the reported event.The unit was installed onto a golden system, where it displayed an image with a total of four vertical lines of different colors one in the middle and three on the right side of the screen.The complaint regarding lines across the screen was confirmed by failure analysis.The probable root cause is attributed to an electrical module issue on hrsv screens, resulting in loss of video.

• 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: 24946574
• Report Number: 2955842-2026-22287
• Device Sequence Number: 21355510
• Product Code: NAY
• UDI-Device Identifier: 00886874114735
• UDI-Public: (01)00886874114735
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 05/28/2026

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: 380940-45
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• 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