MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI; VISION SIDE SYSTEM

Model Number	381121-12
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the customer contacted technical support to report that the left eye vision displayed a purple tint.The customer had already performed troubleshooting and stated the surgeon side console (ssc) image was affected.They placed the same endoscope on another vision side cart (vsc) and there was no issue.Replacing the endoscope did not resolve the problem on the original vsc.The customer planned to perform a hard power cycle on the vsc when the room became available.The procedure was converted to another dv with no report of patient 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.Fse replaced the endoscope controller (ec) due to degraded image quality.The system was tested and verified as ready for use.Isi did receive a da vinci product involved with this complaint to perform failure analysis.The ec was returned for failure analysis, and the reported failure was not confirmed nor replicated.There were no issues found that would be related to the reported failure.The unit was installed and tested into a golden printed circuit assembly (pca) system where the component functioned as expected.The unit was installed into the test system and ran video test, 10 power cycles, and sat idle for one hour.The system showed no errors and had good video on both eyes.The ec worked as normal.The purple tint in left eye vision was not replicated.The probable root cause could not be determined; however, a possible root cause can be attributed to an electrical component failure within the endoscope controller.

• Brand Name: DAVINCI XI
• Common Device Name: VISION SIDE SYSTEM
• 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: 23150483
• Report Number: 2955842-2025-39289
• Device Sequence Number: 18289036
• Product Code: NAY
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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: 381121-12
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2014
• 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