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

Model Number	380723-11
Medical Device Problem Codes	Visual Prompts will not Clear (2281); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2026
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 replaced the master tool manipulator (mtm) to resolve the issue.The system was tested and verified as ready for use.Isi did receive the mtm to perform failure analysis (fa).Fa was able to confirm the reported complaint via system logs.No visual defects related to the reported issue were identified during inspection.Functional testing on the surgeon side console fixture test platform system resulted in failure on rjs printed circuit assembly (pca).An aba swap was performed on the gimbal, confirming the rjs pca assembly as the root cause of the failure.To correct the issue, the rjs pca assembly will be replaced.
Event or Problem Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the customer called to report repeated faults on the universal surgical manipulator (usm), specifically a 25521 error, which prevented one of the surgeons from controlling arm 4.The intuitive surgical, inc.(isi) technical support engineer (tse) reviewed and confirmed the 25521 error related to the right master tool manipulator (mtm) and verified that the site had disabled mtm.The tse advised the customer that the main surgeon could switch to the other surgeon side console (ssc) to control usm 4 without issues.The customer confirmed that the other surgeon was able to control the arm.The procedure was completed as planned with no report of patient injury.

• 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: 25197055
• Report Number: 2955842-2026-25199
• Device Sequence Number: 8889843
• Product Code: NAY
• UDI-Device Identifier: 00886874115374
• UDI-Public: (01)00886874115374
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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: 380723-11
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2021
• 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