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

Model Number	380940-31
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2026
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.Fse replaced the personality module surgeon console (pmsc) to correct the reported problem.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.The complaint was confirmed based on the field evaluation, which indicates that the device may have contributed to the customer reported issue.
Event or Problem Description
It was reported that during a training/demo of the da vinci system, the user encountered a green screen issue displayed only on the surgeon side console's high resolution stereo viewer (hrsv-l), while the vision side cart had no issues.The user conducted both a power cycle and a hard power cycle of the system, but the issue persisted.There was no report of patient involvement or there was no report of patient injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the reporter confirmed that the entire screen on the left eye was solid green with no visible image.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The personality module surgeon console (pmsc) was analyzed and found in the system logs, no history was found to indicate the failure occurred in the field.During visual inspection, both video input leaf (vil) and surgeon console leaf (scl) boards were found damaged due to wear and tear.The pmsc was installed on the golden system to run video and audio tests, 10 power cycles, and sitting idle for one hour.All vil and video output leaf (vol) ports were tested and had good image.Also, audio was tested with clear sound.Once testing was completed, the system error logs was inspected, but no error could be identified.The complaint regarding a green screen only in surgeon side cart (ssc) high resolution stereo viewer (hrsv) was confirmed by failure analysis.The probable root cause is attributed to electrical issues resulted from the scl boards located on pmsc.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 24537812
• Report Number: 2955842-2026-15255
• Device Sequence Number: 13029520
• Product Code: NAY
• UDI-Device Identifier: 00886874114735
• UDI-Public: (01)00886874114735
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 380940-31
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 04/02/2026
• 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: 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