MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI XI; VISION SIDE SYSTEM, RECONDITIONED

Model Number	380721-06
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
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 endoscope controller (ec) and the fiberoptic cable to resolve the issue.The fiberoptic cable is a field scrap item and will not be returned to isi for further investigation.Intuitive surgical, inc.(isi) did receive the ec for failure analysis.The ec was analyzed.In artemis system logs, error 54 was found to indicate the failure occurred in the field.During visual inspection, no damage was observed on the exterior and interior of the ec unit.Failure analysis observed no physical damage to the endoscope receptacle.The ec was installed on the golden system where it was turned on normal mode and triggered error 54.The system logs were investigated and found error 54.This was indicating an issue with the dcib (dual camera interface board).The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause is attributed to an electrical/fiberoptic defect pertaining to the dcib of the ec.This product issue is also captured via risk id xi-vsc-10928 of fmea,endoscope controller,video processor,is4000 and sp1098 (1009327-40, rev.H).The clinical harm is also captured via risk id g4-sys-70272 of is4000 family shared clinical risk analysis (818001-45, rev.Au).Section h: annex b, c, d updated.
Event or Problem Description
Refer to h11 for follow-up information.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did not receive the da vinci product with an alleged issue to perform failure analysis.An rma had been issued requesting to have the isi device returned; however, isi did not receive the rma to confirm/identify the failure mode.The orange fiber cable was replaced successfully, and the system was tested and verified as ready for use.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted simple transvesical prostatectomy surgical procedure, the customer had a message indicating to clean the fiber.Technical support engineer (tse) viewed the system event logs and noticed an error 54 pointing the orange fiber to video processor (vp).Tse asked customer to reseat the orange fiber, but there was no change.Tse asked her to clean the orange fiber, and also no change.Customer asked for fse to resolve the reported problem.The procedure was completing as planned with no reported injury.

• Brand Name: DA VINCI XI
• Common Device Name: VISION SIDE SYSTEM, RECONDITIONED
• 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: 24709945
• Report Number: 2955842-2026-19176
• Device Sequence Number: 6110306
• Product Code: NAY
• UDI-Device Identifier: 00886874115343
• UDI-Public: (01)00886874115343
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131861
• 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): 04/30/2026

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: 380721-06
• 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): Follow-Up
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2019
• 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