MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC daVinci Xi; VISION SIDE SYSTEM

Model Number	381121-17
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to starting a da vinci-assisted surgical procedure, an error occurred during startup and did not clear after a restart.The troubleshooting first confirmed the initial code as a different error code, and it was noted that an extension cable had been in use.The connection was then changed and the unit was restarted, but the error still did not clear.An alternate device was available onsite but had not been integrated, so the integration method was explained and an external pedal option was discussed, though those options were not accepted.After the error, integrated mode had been used and ¿not available¿ had displayed during use, making energy activation unavailable.The installed instruments across all arms were reviewed, and it was considered whether one instrument might have been detected as a second bipolar instrument.Instructions were provided to discontinue integrated operation and set up the external pedal, after which energy output had been available via the pedal even though ¿not available¿ continued to display.The customer was to test further and recontact support if energy output remained unavailable.The procedure was completing as planned 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 integrated electrosurgical unit (iesu) to resolve the customer reported issue.The system was tested and verified as ready for use.The iesu was analyzed and found that a review of system logs revealed error c 33 on reported event date.Visual inspection of the unit revealed no issues related to the reported event.Upon boot, the c 33 error was displayed on startup.The complaint was confirmed based on failure analysis.The probable root cause of error c 33 is attributed to a faulty electrical component inside the iesu.

• Brand Name: daVinci Xi
• 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 ; +1(408)523-2100
• MDR Report Key: 50928040
• Report Number: 2955842-2026-40279
• Device Sequence Number: 10725298
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 381121-17
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/24/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/11/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2015
• 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: Unknown