MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC daVinci 5; Surgeon Side Cart

Model Number	380730-46
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a training/demo of the da vinci system, the clinical sales representative (csr) observed the right master tool manipulator (mtm) was not working properly on the system.A work order was requested for demo/not for human use (nfhu) system due to the right mtm malfunction.Logs were not available at the time of the report.Following a restart of the system, the right mtm remained unstable.It was also noted that ergonomics needed to be checked, though no further information was provided on that matter.There was no report of patient involvement or reported injury.Intuitive surgical, inc.(isi) obtained the following additional information: on this console, none of the ergonomic adjustments were working.The armrest height, pedal depth, and viewer were completely non functional, and the message ¿ergonomics error¿ appeared on the display.The console was restarted several times, and the ergonomics only started working after approximately the fifth restart.However, this did not last long, and the right mtm stopped working during a simulation exercise.The console was restarted several times.In this condition, the console is not suitable for demonstration purposes.
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 master tool manipulator (mtm) to correct the issue.The system was tested and verified as ready for use.Isi did not receive the product involved with this complaint to perform failure analysis.

• Brand Name: daVinci 5
• Common Device Name: Surgeon Side 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 ; +1(408)523-2100
• MDR Report Key: 50927990
• Report Number: 2955842-2026-40303
• Device Sequence Number: 9734264
• Product Code: NAY
• UDI-Device Identifier: 00886874119747
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K232610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 380730-46
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2025
• 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