MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; VISION SIDE SYSTEM

Model Number	380990-15
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
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 illuminator and light guide cable to solve the 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 illuminator was returned for failure analysis due to a burning smell, and the reported complaint was confirmed but not replicated.No error codes were found in system logs.Upon visual inspection, the module lamp drawer was burnt, indicating the lamp overheated, confirming the fault occurred in the field.The unit was then installed and programmed onto the golden system and was set to idle for about an hour with the lights on, but the reported issue was replicated.The system ran 10 power cycles, but no related error codes were triggered during the cycles.The complaint was not confirmed based on failure analysis.The missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.Field h10 is blank as there are no related report numbers.
Event or Problem Description
It was reported that during a da vinci-assisted prostatectomy surgical procedure, the customer informed intuitive surgical, inc.(isi) technical support engineer (tse) that a burning smell was noted on the illuminator.There was no system error.The customer elected to use a third-party illuminator to continue with the procedure.The procedure was completed as planned with no reported injury.Isi followed up with the nurse and obtained the following additional information: illuminator and the bulb connecting place burnt.The customer stated that the burning smell was heavy, and the illuminator was not working.Replacing the illuminator with a third-party illuminator was the only way to continue the procedure.

• Brand Name: DAVINCI SI
• Common Device Name: VISION SIDE SYSTEM
• 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: 25052478
• Report Number: 2955842-2026-23493
• Device Sequence Number: 9965268
• Product Code: NAY
• UDI-Device Identifier: 00886874110874
• UDI-Public: (01)00886874110874
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: 380990-15
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2015
• 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: Male