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

Model Number	380941-44
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the customer contacted tech support engineer (tse) to report that the system had an error 323 indicating a problem with the energy shield monitor (esm).Tse walked the customer through a hard power cycle on the esm and the tower and checked all power and communication cables with no change.The procedure was aborted to another dv system/no patient involvement with no reported injury.
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.After replacing energy shield monitor (esm) due to error 323, fse continued to program the new esm; however, node csm_pic was not reporting and was unable to program.Fse then checked cables in the back of the tower and noticed that the low voltage differential signaling (lvds) cable on the core was not plugged into the bottom port but plugged into the top port.Fse then switched the cable from the top port to the bottom and was able to program node.Fse then performed system power cycle and was able to successfully complete system verification.The system was tested and verified as ready for use.Intuitive surgical, inc.(isi) did receive a da vinci product involved with this complaint to perform failure analysis.The esm was returned for failure analysis, and the reported 323 error was confirmed but not replicated.In system logs, the 323 error was found indicating node not present, confirming the fault occurred in the field.Upon visual inspection, no issues were found that would be related to the reported event.The unit was installed onto a golden system and functioned as expected.The complaint was confirmed based on failure analysis.While the root cause could not be determined based on failure analysis, the cause is likely due to an electrical component failure within the esm.

• 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: 24809788
• Report Number: 2955842-2026-20746
• Device Sequence Number: 13432674
• Product Code: NAY
• UDI-Device Identifier: 00886874114742
• UDI-Public: (01)00886874114742
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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: 380941-44
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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