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

Model Number	380721-11
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted umbilical hernia ipom surgical procedure, the erbe had repeated errors coming from the system.The technical support engineer (tse) reviewed the logs and confirmed the errors were from the erbe unit.Error c-83 had errors without energy being applied.The tse informed the customer that they had the option to use a third-party generator with the system to hold them over for the day, since they had multiple cases left for the day.The tse educated them on how to set up the third-party generator.The customer was no longer receiving any errors at the moment but would use it if needed.The erbe had faulted and getting c-82/c-83/c-84 errors on the screen, however the monopolar and bipolar energy was working intermittently.The customer tried new monopolar and bipolar energy cords, tried plugging into both energy ports on the erbe but the issue remained.The logs confirmed c-82/c-83/c-84 errors.The tse recommended trying to reboot the erbe.The customer rebooted the erbe and it powered back on, and the surgeon tested the energy and the c-82 error returned.The procedure was completed with no reported 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 went on-site and replaced the integrated electrosurgical unit (iesu).The system was verified and ready for use.Isi received the iesu to perform failure analysis.The reported issue was confirmed recurring errors.Functional testing revealed that the unit powered on normally and successfully cauterized across all ports and instruments without issue.However, a review of the internal erbe error log showed errors.The complaint was confirmed by failure analysis.

• 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: 24915469
• Report Number: 2955842-2026-22075
• Device Sequence Number: 9269392
• Product Code: NAY
• UDI-Device Identifier: 00886874115343
• UDI-Public: (01)00886874115343
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/17/2026

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: 380721-11
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2022
• 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