MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI XI; SURGEON SIDE CONSOLE, RECONDITIONED

Model Number	380723-10
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 personality module surgeon console (pmsc) to resolve error 48200 issue.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 pmsc was analyzed and the reported problem error 48200 on pmsc was confirmed.In artemis, there was error 48200 found to indicate the failure occurred in the field.Visual inspection, dvi ports on both scls were found damaged due to wear and tear.The pmsc was installed onto the golden system where the component functioned as expected.The golden system was set to run 10 power cycles and sitting idle for 45 minutes.Once testing was completed, the system error logs was inspected, but no error could be identified.The complaint was confirmed based on investigation results, which indicates that the device may have contributed to the customer reported issue.As a result of these findings, failure analysis concluded that the damage of digital video interface (dvi) ports on surgeon console leaf (scl)-1 is root cause of the reported issue.
Event or Problem Description
It was reported that during a training/demo of the da vinci system, error 48200 occurred and the left eye on the surgeon side console (ssc) was dark.Customer tried both a power cycle and a hard cycle, but the issue persisted.Technical support engineer (tse) confirmed that error 48200 pointed to the personality module surgeon console (pmsc).Tse advised customer to change the console, and this resolved the issue.Tse explained to customer that ssc required repair.There was no report of patient involvement.

• Brand Name: DA VINCI XI
• Common Device Name: SURGEON SIDE CONSOLE, 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: 24722494
• Report Number: 2955842-2026-19653
• Device Sequence Number: 10139091
• Product Code: NAY
• UDI-Device Identifier: 00886874115374
• UDI-Public: (01)00886874115374
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131861
• 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
• Report Date (Section B): 03/27/2026

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: 380723-10
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2020
• 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