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

Model Number	380675-04
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Field service engineer (fse) replaced the printed circuit assembly (pca) power board and the patient side cart (psc) battery box to resolve the issue.Intuitive surgical, inc.(isi) received the replaced power board for failure analysis.Failure analysis investigation confirmed the fault during functional testing.Investigation confirmed a component failure.An rma was issued to evaluate the battery box.Additional information is being gathered to determine the contribution of the device to the customer reported issue.Complaints are tracked via the qms processes per wi 859369 (quality data review meetings).
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the customer encountered a non-recoverable fault 17.The customer swapped out cables and hard power cycled the system but the error returned.The customer ended the call and requested service on the system.The procedure was completed with no reported injury.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, 4-ARM, RECERTIFIED
• 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: 24710084
• Report Number: 2955842-2026-18954
• Device Sequence Number: 20278119
• Product Code: NAY
• UDI-Device Identifier: 00886874110737
• UDI-Public: (01)00886874110737
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K123463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: 380675-04
• Device Catalogue Number: 380675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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