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

Model Number	380941-50
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted left hemicolectomy surgical procedure, the customer contacted intuitive surgical, inc.(isi) technical support engineer (tse) and reported that a non-recoverable fault code indicating monopolar energy was not available during system setup, with no patient involved.Technical support first instructed the customer to power cycle the system using emergency power off (epo) and to reseat the fiber cables as well as the energy shield monitor (esm), but the error persisted after each attempt.Technical support verified that cables were properly connected.System logs were not accessible, so further troubleshooting was limited.Isi field service engineer (fse) was dispatched to site to further troubleshoot.The procedure was aborted with no patient involvement with no reported injury.
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 energy shield monitor (esm).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 esm was analyzed and in artemis the error 32209 was seen confirming the error occurred in the field.Upon visual inspection no issues were found.The unit was installed onto a golden system and functioned as expected.All ports and connections were tested with no issues, all leds were seen on and functional.The unit was also left to idle for about 2 hours however no faults or errors were triggered.The complaint was confirmed based on failure analysis, which indicates that the device may have contributed to the customer reported issue.

• 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: 24709994
• Report Number: 2955842-2026-19047
• Device Sequence Number: 6121439
• Product Code: NAY
• UDI-Device Identifier: 00886874114742
• UDI-Public: (01)00886874114742
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: 380941-50
• Device Catalogue Number: 380941
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2025
• 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