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

Model Number	380941-34
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An intuitive field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Based on the field evaluation, this reported event was able to be replicated.The fse replaced the endoscope controller (ec) and the video processor (vp).The system was tested and verified as ready for use.The ec was returned to failure analysis (fa), and the reported problem could not be replicated, however, system logs did confirm an error indicating the failure occurred in the field.Upon visual inspection, no damage was observed on the interior or exterior of the unit.Fa observed no physical damage to the endoscope receptacle.The ec was installed on the golden system and functioned as expected.All nodes were present, and the image was clear on both the vision side cart (vsc) and surgeon console controller (scc).The leds on the endoscopic controller power distribution (ecpd) and dual camera interface board (dcib) were present.They system was set to run 10 power cycles.After testing, the error logs were investigated, but no error was found related to the reported event.Intuitive has received the vp to perform failure analysis.However, as of the date of this report, the evaluation has not been completed.
Event or Problem Description
It was reported that after the start of a da vinci-assisted tongue base resection procedure, the vision side cart (vsc) was encountering repeated system faults.Prior to calling the intuitive surgical inc.(isi) technical support engineer (tse), the site had already exchanged the scope and performed a hard power cycle of the system; however, the issue did not resolve.The procedure was aborted after anesthesia was administered but incision ports had not been placed.The customer stated the patient tolerated the aborted procedure with no reported injuries or postoperative complications.The surgery was rescheduled and completed 5 days later.
Additional Manufacturer Narrative
Updated fields: h2, h6, h11.Additional information: the video processor (vp) unit was returned for failure analysis (fa), and the reported event was not able to be confirmed or replicated.System logs were reviewed, and no error were present in relation to the vp.Initial visual inspection noted the vp unit was received with no filter.The unit was tested on in-house systems and power cycles operations were performed.The unit performed successfully with no error codes present.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 24899158
• Report Number: 2955842-2026-21046
• Device Sequence Number: 8640571
• Product Code: NAY
• UDI-Device Identifier: 00886874114742
• UDI-Public: (01)00886874114742
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 380941-34
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2019
• 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: Reuse
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 60 KG
• Patient Ethnicity: Hispanic