MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; PATIENT SIDE CART, 4-ARM

Model Number	380614-12
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
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 complaint.The fse was able to reproduce the issue and replaced the patient side manipulator (psm).The system was tested and verified as ready for use.The psm involved with this event has been received, but the failure analysis testing has not yet been completed as of the date of this report.The missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer contacted the da vinci surgery technical assistance team (dvstat) and reported that they had a fault.The customer stated that the patient side manipulator (psm) 3 pitch axis could not move.Before calling dvstat, the customer had hard power cycled the system and the issue remained.Then the technical support engineer (tse) checked the error log with the field service engineer (fse) and found the system reported error 23008, pointing to axis 2.The tse recorded the information and the fse would go on site for further troubleshooting.The procedure was completing as planned with no reported injury.
Additional Manufacturer Narrative
The patient side manipulator (psm) has been evaluated by the failure analysis (fa) team.Fa was able to confirm the reported complaint via system logs.Fa installed the psm onto a golden system where error 23007 was triggered on startup, indicating that the servo system was unable to control the arm within expected tolerances during the wiggle test performed after homing, with p-values pointing to axis 2, replicating the reported event.Due to error 23007, further functional testing could not be completed.After testing was complete, excessive brake dust was found from axis 2, but no other issues were found related to the reported event.Based on these findings, fa determined that the axis 2 pot assembly is the root cause of this issue.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, 4-ARM
• 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: 24206848
• Report Number: 2955842-2026-02516
• Device Sequence Number: 5484166
• Product Code: NAY
• UDI-Device Identifier: 00886874110690
• UDI-Public: (01)00886874110690
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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: 380614-12
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2014
• 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: 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