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

Model Number	380941-50
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
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 event.Fse replaced the auxiliary video board (avp) and energy shield monitor (esm) to resolve the issue.The system was tested and verified as ready for use.Isi did receive the da vinci products involved with this complaint to perform failure analysis.The avp was analyzed and was found to have electrical/fiberoptic defects resulting in the component not functioning during testing.The complaint was confirmed based on the results of the investigation, which indicates that the device may have contributed to the customer reported issue.Failure analysis for esm has not been completed yet.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted radical tonsillectomy surgical procedure, error 32209 occurred.Prior to calling technical support, clinical sales representative (csr) power cycled system but error persisted.All leds on the energy shield monitor (esm) were flashing yellow.Intuitive surgical (is) technical support engineer (tse) asked csr to power off the system and guided csr through to verify the integrity of all connections on esm and related connections on core and video processor (vp).Csr verified all connections were seated properly.Tse also guided csr to verify connections between erbe and esm, all verified.Tse had the csr toggle circuit breaker on esm.After restart system started up with same error 32209 and all leds on esm were still flashing yellow.System was not connected to onsite during call, so no relevant logs could be obtained.Csr informed tse that the procedure will be performed as an open surgery due to the issue.There was no report of patient injury.

• 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: 24710031
• Report Number: 2955842-2026-19044
• Device Sequence Number: 12181835
• Product Code: NAY
• UDI-Device Identifier: 00886874114742
• UDI-Public: (01)00886874114742
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: 380941-50
• Device Catalogue Number: 380941
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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