MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI XI; VISION SIDE SYSTEM, RECONDITIONED

Model Number	380721-10
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted an issue previously identified had returned, resulting in the system presenting nonrecoverable fault 86.Staff indicated that this fault occurred even after having worked with a technical support engineer, and the site planned to use a different video tower to continue with the procedure.No troubleshooting steps had been completed initially.Subsequently, the system experienced two nonrecoverable faults during a case, and the customer performed a power cycle to recover and continue.After the call ended, error 86 appeared again and was related to the ipd.Troubleshooting steps had not been fully completed, and the customer was advised to call back if the error returned before another power cycle.The procedure was converted to another dv system with no reported 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.The fse replaced the redundant power tray assembly core to resolve the 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 redundant power tray was analyzed.In system logs, report error 86 was found indicating the fault confirming the fault occurred in the field.Visual inspection, no issues were found that are related to the report issue.The unit was installed on a golden system for additional testing.Performance program process into system no problem so far, startup the system power on no error and after system power cycles for 10x where the failure was again, successfully replicated error 86 show up after system power cycles test.The complaint was confirmed based on the failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause is attributed to an electronic defect of the intuitive surgical core power distribution (ipd) printed circuit assembly (pca) in the redundant power tray.

• Brand Name: DA VINCI XI
• Common Device Name: VISION SIDE SYSTEM, 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: 25117724
• Report Number: 2955842-2026-24337
• Device Sequence Number: 9292510
• Product Code: NAY
• UDI-Device Identifier: 00886874115343
• UDI-Public: (01)00886874115343
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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: 380721-10
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2021
• 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