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

Model Number	380610-17
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse found error 121 in the logs.The fse replaced the high-resolution stereo viewer (hrsv).The system was tested and verified as ready for use.Isi has not received the device for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer had lost vision in the right eye of the high-resolution stereo viewer (hrsv).The customer stated that the right eye port light was dim.The customer hard power cycled the system, and the right eye showed a color bar, but the light was still dim.The procedure was completing as planned with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the high-resolution stereo viewer (hrsv) associated with this complaint 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 and powered on showing a blank screen.The probable root cause is a failure of the hrsv monitor.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 21121074
• Report Number: 2955842-2025-00121
• Device Sequence Number: 12941521
• 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,Followup
• Report Date (Section B): 12/17/2024

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: 380610-17
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2014
• 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 Sex: Unknown