MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI 5; VISION SIDE CART

Model Number	380746-40
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2026
Type of Reportable Event	Malfunction
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.Based on the field evaluation, this reported event was confirmed.Fse was able to replicate the reported issue.Fse replaced the master tool manipulator to resolve the issue.The system was tested and verified as ready for use.Failure analysis replicated and confirmed the reported complaint.A review of field lighthouse logs showed the unit experienced the following error codes: 32145 system_err_local_hs_sw_post_retry_fault, 48289.System_err_swless_node_programming_failed, 32139 system_err_local_hs_sw_post_fault, 46603 sentry_adv_signal_alarm, 32101 system_err_local_frl_hs_sw_fault, 25743 error_uce_hw_remote, 40014 code_err_null_ptr.A visual inspection was performed and revealed no external damage.The unit was then tested on the in-house system and failed, exhibiting the same errors as observed in the field.The unit was installed for further fitness tests and a one-hour sine cycle; it failed again.An aba swap was performed with in-house pca boards mcmbd1 and mcmbd2; however, the unit continued to fail.Next, the mcmw pca was swapped out but the unit still failed.Swapping the mcmp pca resulted in initial passage, but the unit subsequently failed at the home manipulation test.Upon further investigation, failure analysis determined that the gimbal was the root cause of the failures.
Event or Problem Description
It was reported that prior to starting a da vinci assisted surgical procedure, the customer experienced non-recoverable 40014 error occurring during system startup while the system was configured in dual console mode.Technical support had the staff remove one console, after which the system started successfully and completed self test.At the time of troubleshooting, the system remained disconnected so logs were not available, and the system connection was reestablished shortly after the call ended.There was no report of patient involvement or reported injury.

• Brand Name: DAVINCI 5
• Common Device Name: VISION 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 ; 4085232100
• MDR Report Key: 25022930
• Report Number: 2955842-2026-23085
• Device Sequence Number: 13327322
• Product Code: NAY
• UDI-Device Identifier: 00886874119662
• UDI-Public: (01)00886874119662
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K232610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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: 380746-40
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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