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

Model Number	380610-20
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
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.Fse advised customer to remove the surgeon side cart (ssc) from use and the system restarted with no errors.Customer proceeded laparoscopically and not commence with one surgeon console.Fse then replaced the right master tool manipulator (mtmr) and rac2 to resolve the issue.System passed all calibrations.System was tested and verified ready for use.Isi has not received the devices 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 malignant hysterectomy surgical procedure, customer contacted intuitive surgical, inc.(isi) technical service engineer (tse) and reported that there was a non-recoverable fault.Customer was not able to provide any error code details.Tse checked logs and found issues pointing to rac2 (master tool manipulator right (mtmr)) on surgeon side console (ssc).Prior to the contacting tse, customer already restarted system multiple times, but issue persisted.Tse advised customer to disconnect broken ssc and continue procedure with second ssc.After restart, system was ready for use and procedure was completing as planned.There was no report of patient harm due to this event.Isi followed up with the initial reporter and obtained the following additional information: the customer had an issue with the si system.The tse advised customer to restart the system with the suspect ssc not connected and the system started as normally.Customer however decided to convert and proceed with the case as laparoscopic, not robotically with one ssc.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the master tool manipulator 2 (mtm2) involved with this complaint to perform failure analysis and the reported error fault was confirmed but not replicated.In remote logs, the 23017 error was found indicating axis 1 motor did not respond as expected, confirming the fault occurred in the field.Upon visual inspection, no issues were found that would be related to the reported event.The mtm2 was installed onto a golden system where the component functioned as expected.The mtm2 was then installed onto a patient side cart fixture test platform (pftp) where all relevant testing was passed within specification.Once testing was completed no faults could be identified.As a result of these findings, failure analysis concluded that axis 1 motor is consistent with the reported event and is the potential root cause for this issue.Additionally, the remote arm controller (rac) board was analyzed and the error was confirmed via error system logs.In remote logs, report data was found to indicate that the fault had occurred in the field.There were no issues during the visual inspection.The rac was installed onto a printed circuit assembly (pca) system where the component functioned as expected; then, the golden system was set to run 10 minutes sine cycle, 10 power cycles and sitting idle for 1 hour.Once the testing was completed, as a result of these findings, the failure analysis determined that no definitive root cause could be identified for this issue.However, a review of customer error 25593 indicates a wheel communication problem between the armnet and the rac.The complaint was confirmed based on failure analysis.The probable root cause is attributed to an electrical failure with the axis 1 motor within the mtm and a wheel communication issue between the armnet and the rac board.
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: 21077977
• Report Number: 2955842-2024-23973
• Device Sequence Number: 6888498
• Product Code: NAY
• UDI-Device Identifier: 00886874110683
• UDI-Public: (01)00886874110683
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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: 380610-20
• 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: 12/09/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2015
• 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: Female