MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI SP; VISION SYSTEM CART

Model Number	380941-51
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted pyeloplasty surgical procedure, the customer was having an error 319 at start up.Prior to contacting technical support, customer tried hard power cycling the system with no improvement.Technical support engineer (tse) tried checking error logs but system was not connected to onsite.Tse reviewed the error logs and confirmed that the error was pointing to the endoscope controller (ec).Tse guided customer to check all power cables in the power strip and push them in.Tse guided customer to hard power cycle the system and check all blue fiber cables (bfc) as the patient side cart (psc) did not power on with the rest of the system, but there was no improvement.Tse guided customer to push the power cable in the ec and try a different one, as well as reconnect the orange fiber able in both the ec and the video processor (vp), with no improvement.Customer confirmed that the error was still pointing to the same node and tse explained that the ec would need to be service as it seemed to be dead.Customer explained they would have to cancel the surgery.The procedure was aborted 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 replaced the endoscope controller (ec).The system was tested and verified as ready for use.Isi did not yet receive a da vinci product involved with this complaint to perform failure analysis.The complaint was confirmed based on the field evaluation.The investigation to determine the cause of this reported event is currently in progress.

• Brand Name: DA VINCI SP
• Common Device Name: VISION SYSTEM CART
• 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: 24709880
• Report Number: 2955842-2026-19036
• Device Sequence Number: 5777656
• Product Code: NAY
• UDI-Device Identifier: 00886874114742
• UDI-Public: (01)00886874114742
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: 380941-51
• Device Catalogue Number: 380941
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2025
• 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: Unknown