MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC da Vinci Xi; SURGEON SIDE CONSOLE, RECONDITIONED

Model Number	380723-12
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to starting in a da vinci-assisted surgical procedure, no ports placed, the customer identified vision side cart (vsc) did not progress self-test and surgeon side console (ssc) displayed message not connected to vision side cart (vsc).Technical support engineer (tse) observed recoverable error message/fault 31016, pointing at ssc being at different software level than vsc.The customer elected to swap ssc available on site to continue with the procedure.
Additional Manufacturer Narrative
An intuitive field service engineer (fse) was dispatched to the customer site to further investigate the reported event.Based on the field evaluation, the fse updated software on surgeon side console (ssc).Service performed to correct reported problem.No part replacement required.System inspected, tested and verified as ready for use.

• Brand Name: da Vinci Xi
• Common Device Name: SURGEON SIDE CONSOLE, 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: 50185201
• Report Number: 2955842-2026-35135
• Device Sequence Number: 13263912
• Product Code: NAY
• UDI-Device Identifier: 00886874115374
• UDI-Public: (01)00886874115374
• 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): 08/07/2026

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: 380723-12
• Device Catalogue Number: 380723
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2022
• 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: Reuse
• 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