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

Model Number	380723-19
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
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse was able to reproduce the issue and replaced the master tool manipulator (mtm).The system was tested and verified as ready for use.As of the date of this report, the mtm has not yet been received by intuitive surgical, inc.(isi) for evaluation.Therefore, the root cause of the reported failure mode has not yet been determined.
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy radical with lymphadenectomy surgical procedure, that the right master tool manipulator (mtm) was dropping during clinical use, and error 23075 was detected, indicating right mtm drift.The system was configured with four universal surgical manipulator (usm) arms, and the issue persisted with the secondary instrument on the usm 3.The instruments were swapped between usm arms, but the problem remained.The procedure was completing as planned with no reported injury.Intuitive surgical, inc.(isi) followed up and obtained the following additional information: according to the customer, the total delay experienced was approximately 40 minutes, and the operative time for the surgical procedure was about 4 hours.It was confirmed that there were no data (nd) indicating any intra or post-operative complications due to the delay.Furthermore, the surgeon did not report any impact on the procedure or the patient¿s health as a result of the event, nor were there any concerns expressed regarding long-term complications arising from the delay.

• 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: 24815788
• Report Number: 2955842-2026-20794
• Device Sequence Number: 13160456
• Product Code: NAY
• UDI-Device Identifier: 00886874115374
• UDI-Public: (01)00886874115374
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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: 380723-19
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• 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: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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: Male