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

Model Number	380620-47
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure that non-recoverable fault 32056 occurred against universal surgical manipulator (usm) 4.As system was onsite, the intuitive surgical inc technical support engineer (tse) reviewed the system logs and found faults against a board inside usm 4.The tse asked the caller if they would be able to proceed with three usms; the caller was unsure as the surgeon was not in the room yet.The procedure outcome not provided.The ports were not in place when the issue occurred.Isi contacted the initial reporter and obtained the following information: there was no harm to the patient, and the procedure was aborted to an open procedure.
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 reported complaint and replaced the universal surgical manipulator (usm).The system was tested and verified as ready for use.As of the date of this report, the usm has not yet been received by isi for evaluation.

• Brand Name: daVinci X
• 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 ; +1(408)523-2100
• MDR Report Key: 50850381
• Report Number: 2955842-2026-39635
• Device Sequence Number: 21206772
• Product Code: NAY
• UDI-Device Identifier: 00886874115404
• UDI-Public: (01)00886874115404
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171294
• 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
• Report Date (Section B): 09/21/2026

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: 380620-47
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2023
• 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