MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC da Vinci Xi; VISION SIDE SYSTEM, RECONDITIONED

Model Number	380721-09
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted retroperitoneal anterior partial nephrectomy surgical procedure, an intuitive surgical (is) technical support engineer (tse) was contacted for by the customer to report that the system shuts down by itself, mid procedure.As system was not onsite connected, no logs were available, tse asked customer to take pictures on the event logs in the touchscreen of the vision side cart (vsc), but nothing received yet.No idea what triggered the shut down or on which surgeon side console (ssc).A field service engineer (fse) would need to go on site to upload the logs so they can be analyzed to see what are the recommended actions.System was hard power cycled due to other problems.The procedure was completed with no patient 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.Fse replaced the auxiliary video board (avp) to correct the reported event.The system was tested and verified as ready for use.Isi did not receive a da vinci product involved with this complaint to perform failure analysis.The complaint was confirmed based on the field evaluation, which indicates that the device may have contributed to the customer reported issue.

• Brand Name: da Vinci Xi
• Common Device Name: VISION SIDE SYSTEM, RECONDITIONED
• 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: 50877566
• Report Number: 2955842-2026-39837
• Device Sequence Number: 9223817
• Product Code: NAY
• UDI-Device Identifier: 00886874115343
• UDI-Public: (01)00886874115343
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 380721-09
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/16/2020
• 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