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

Model Number	380941-45
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
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.The fse replaced the iesu to resolve the reported 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 erbe iesu unit was analyzed and found recurring error c-33 upon startup; however, the fuse box was configured for 230 and contained two 4a fuses.For testing purposes, the configuration was adjusted by switching to two 8a fuses and setting the unit to 115 vac.After powering on the erbe unit, error code c-33 reappeared upon startup.The fuses were then replaced back to two 4a fuses, and the iesu was reconfigured to 230 vac.A review of the erbe log showed error c-00.Upon visual inspection, the unit was found to have light scuffs and scratches on the front gray bezel, as well as scratches on the heatsink.Additionally, there were areas of paint touch-up and chipped paint on the cover/housing.The root cause of the reported event is attributed to a component failure of the iesu.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, c-00 and c-33 errors appeared on integrated electrosurgical unit (iesu) after startup of the system.Customer performed power cycle of iesu; however, the same issue persisted.The procedure was aborted with no report of patient involvement.

• 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: 24709984
• Report Number: 2955842-2026-19068
• Device Sequence Number: 6088454
• Product Code: NAY
• UDI-Device Identifier: 00886874114742
• UDI-Public: (01)00886874114742
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care 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: 380941-45
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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