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

Model Number	380721-10
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
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 the integrated electrosurgical unit (iesu) to correct the reported event.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 iesu was analyzed and found the issue could not be confirmed during initial verification using system logs, visual inspection during the fa process validated that the unit does not power on.Because the unit fails to power up, erbe error logs and system-level diagnostic tests could not be accessed, preventing further assessment.The complaint was confirmed based on the field evaluation, which indicates that the device may have contributed to the customer reported issue.
Event or Problem Description
It was reported that during a da vinci-assisted umbilical hernia tapp surgical procedure, user informed the technical support engineer (tse) that the erbe unit lost power during use.The user noted that the erbe was plugged into a wall outlet, which was shared with other devices.The tse recommended trying to plug the erbe power cord into a different outlet or bank of outlets.However, tracing the erbe power cord proved difficult, and the user waited for an opportunity to unplug the erbe and try a new outlet.After waiting for 15 minutes or more, the user had not yet had the chance to move the erbe power cord.The user planned to call back once they could attempt to resolve the issue by changing the outlet.The user continued with the procedure as planned.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: the reporter stated that they completed the procedure without needing energy from the erbe generator.The user used different system in another room for subsequent procedures and the erbe generator was replaced later that same day by a field service engineer.
Additional Manufacturer Narrative
The probable root cause of customer reported issues is attributed to the faulty electrical component inside the generator.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 24866503
• Report Number: 2955842-2026-21343
• Device Sequence Number: 15712493
• Product Code: NAY
• UDI-Device Identifier: 00886874115343
• UDI-Public: (01)00886874115343
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 05/27/2026

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: 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: 03/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2021
• 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