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

Model Number	380723-11
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported event.The fse swapped the high resolution stereo viewer (hrsv) monitor cable from the right to the left eye to isolate the issue.The problem shifted with the monitor cable, indicating that the hrsv itself was functioning properly and that the issue was related to the personality module surgeon console (pmsc).The pmsc was replaced, and the system was tested and verified as ready for use.Isi did not receive a da vinci product involved with this complaint to perform failure analysis.
Event or Problem Description
It was reported that prior to starting a da vinci-assisted procedure, the right eye vision of the high-resolution stereo viewer (hrsv) on the surgeon side console (ssc) appeared pink.An initial system power cycle was attempted to resolve the issue, but the problem persisted.An intuitive surgical inc.(isi) technical support engineer (tse) was consulted and recommended performing another power cycle and reseating the blue fiber cable (bfc) on the ssc.However, the vision issue was not resolved.As a result, the surgery was converted to a minimally invasive cardiac surgery (mics) coronary artery bypass grafting (cabg).The patient tolerated the change well, and the procedure was completed without further complications.Additional information has been requested; however, no response has been received.
Additional Manufacturer Narrative
Updated sections: d9, g3, g6, h2, h6, h11.Device evaluation: intuitive surgical, inc.(isi) received the personality module surgeon console (pmsc) for failure analysis evaluation.There were no errors that were identified in the logs to confirm the reported event in the field.A visual inspection revealed no issues related to the event.The unit was installed on a surgeon side console (ssc) and recognized by the system.The pmsc was tested and power cycled 10 times without any related issues observed.The unit was also tested using an external video cart monitor and with tilepro, and it functioned as expected.Additional information: it was reported that prior to starting a da vinci-assisted coronary artery bypass graft (cabg) procedure, an issue occurred after port placement, but it is unclear what surgical task was underway at the time.There was no patient injury or bleeding.The following details remain unknown: postoperative complications, concerns for long-term complications, and the patient¿s current status.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 24743432
• Report Number: 2955842-2026-19866
• Device Sequence Number: 8772568
• Product Code: NAY
• UDI-Device Identifier: 00886874115374
• UDI-Public: (01)00886874115374
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Nurse
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: 380723-11
• Device Catalogue Number: N/A
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2021
• 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: 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 Sex: Unknown