MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI SP; VISION SYSTEM CART

Model Number	380941-45
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Fse replaced the auxiliary video processor (avp) to resolve the reported issue.The system was tested and verified as ready for use.Isi did receive the avp involved with this complaint to perform failure analysis.Failure analysis confirmed but could not replicate the reported complaint.Error 40068 was found upon reviewing the error logs.Upon visual inspection, no issue related to the reported failure was found.The avp was installed and tested on an in-house system, where the component functioned as expected.The system was programmed and started up without any error.The complaint was confirmed based on failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause cannot be determined based on failure analysis and field evaluation.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, error 32209 occurred repeatedly when the system was powered on.The user rebooted the system but the issue persisted.Technical support engineer (tse) had the customer perform a hard power cycle of the system, but the issue persisted.Onsite was not available at the moment.Tse checked the event logs and found error 32209 with errors 317 and 40068.The procedure was aborted with no report of patient involvement.

• Brand Name: DA VINCI SP
• Common Device Name: VISION SYSTEM CART
• 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: 24682857
• Report Number: 2955842-2026-17697
• Device Sequence Number: 13272334
• Product Code: NAY
• UDI-Device Identifier: 00886874114742
• UDI-Public: (01)00886874114742
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• 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
• Report Date (Section B): 03/24/2026

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: 380941-45
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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