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

Model Number	380610-21
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2026
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 was able to reproduce the reported issue and replace the high resolution stereo viewer (hrsv) monitor and personality module surgeon console (pmsc).The system was tested and verified as ready for use.Isi did receive the da vinci products involved with this complaint to perform failure analysis.The hrsv was returned for failure analysis, and the reported problem was replicated.No error codes were found in system logs.Upon visual inspection, no issue was found that would relate to the complaint.The unit was then installed onto the golden system where the hrsv was initially displayed a "no signal", but after a while it disappeared and the screen displayed no image at all; it was totally black.The pmsc was not replicated.No data was found in system logs to indicate the failure occurred in the field.A visual inspection found no issues related to the report.The pmsc was installed onto the golden system, and all the output and input ports had a good image.The right and left eye images were normal.The golden system was set to run 10 power cycles and sit idle for 45 minutes.Once testing was completed, no error could be identified in system logs.The complaint was confirmed based on failure analysis and field evaluation.The probable root cause is attributed to hrsv monitor.
Event or Problem Description
It was reported that prior to starting a da vinci assisted surgical procedure, the system was checked and one of the surgeon console's (ssc) high resolution stereo viewer's (hrsv) eyes had a blank display.Troubleshooting was performed via power cycle; however, the issue persisted.The planned procedure was aborted.No report of patient involvement.

• Brand Name: DAVINCI SI
• 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: 24508114
• Report Number: 2955842-2026-15033
• Device Sequence Number: 9870226
• Product Code: NAY
• UDI-Device Identifier: 00886874110683
• UDI-Public: (01)00886874110683
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: 380610-21
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2017
• 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