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

Model Number	380610-20
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
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.Fse replaced high-resolution stereo viewer (hrsv) to resolve the issue.The system was verified and ready to use.Isi has not received the hrsv for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.
Event or Problem Description
It was reported that during a da vinci-assisted ureteroureterostomy surgical procedure, the surgeon side cart (ssc) high-resolution stereo viewer (hrsv) right side had no video.The technical service engineer (tse) guided site to replace the backup endoscope and hard power cycle the system.Then tse guided site to reseat the blue fiber.Also, tse suggested site to set the 3d mode to 2d mode.However, the issue was not resolved.There was no reported injury.Intuitive surgical inc.(isi) followed up with the customer to confirm that the system powered on with no errors and was functional.The system was hard powered cycled, and the endoscope was replaced to resolve the issue.The procedure was completed robotically with original configuration.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product involved with this complaint to perform failure analysis.The high-resolution stereo viewer (hrsv) was analyzed and found to the reported issue was not replicated or confirmed.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 on our printed circuit assembly (pca) test system, and it started up without any errors.The image quality was sharp, no noise, and not tinted.Additionally, 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 the unit was showing a blank screen.As a result of these findings, failure analysis was able to conclude that an electrical component issue in the touchscreen was found to be the cause of the reported failure.The complaint was confirmed based on the field evaluation and failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause is attributed to an electrical component issue within the touchscreen from the hrsv.

• 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: 21215713
• Report Number: 2955842-2025-00737
• Device Sequence Number: 8786092
• 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): 01/09/2025

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: 380610-20
• 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): Initial
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2015
• 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: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian