MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI SI; PATIENT SIDE CART, 4-ARM

Model Number	380614-14
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive the da vinci products to perform failure analysis.The battery box was analyzed and the complaint was confirmed by failure analysis.In remote, the error 802 was found indicating the fault, confirming the fault occurred in the field.Visual inspection: found connector was broken that is related to the report issue.The battery box was installed onto a golden system (is3000) where the failure was triggered battery fault indicating fault on the battery box, replicating the reported event.The generic power distributor (gpd) was analyzed, and the complaint was confirmed by failure analysis.The gpd was returned for failure analysis, and the reported issue was not replicated.Upon visual inspection, no issues were found that would be related to the reported event.In remote fe and artemis, no data was found to indicate that the fault had occurred the field.The gpd board was installed on the printed circuit assembly (pca) si test system and was powered on showing no errors.Conducted the vision test and verified that the monitors are working.Verified the power switches and epo buttons worked.The voltage and current status are normal.Conducted 15 power cycles and a 5-minute sine cycle with no issues.As a result of these findings, failure analysis concluded that no root cause could be attributed to this issue.This unit was returned with a psc battery that caused the issue.The aux power board (apb) have been returned and evaluated by the failure analysis team on 03/03/2025.In remote fe and artemis, the errors 86, 802, 817 was found indicating the fault, confirming the fault occurred in the field.Visual inspection, no issues were found that is related to the report issue.The apb board was installed onto a golden system where the component functioned as expected.Then the golden system was set to run video test, 10 minutes sine cycle, 10 power cycles & sitting idle for 1 hour.Once the testing was completed, the system error logs were inspected, but no error could be identified.The root cause was identified as a broken connector on the battery box.This physical damage was directly related to the reported issue.Error code 802, observed in remote logs, confirmed the fault in the field.When retested on a golden system, the battery box triggered the same fault condition reported by the customer.However, the unit was returned with a patient side cart (psc) battery that was confirmed to have caused the reported issue.Therefore, the issue was not attributable to the gpd itself.The probable external cause is the faulty accompanying battery, not the gpd.Although error codes (86, 802, 817) confirming a field fault were found in remote monitoring, exhaustive functional and stress testing on the apb and system error logs failed to reproduce or confirm a hardware problem.There were no visual indications of damage or malfunction.
Event or Problem Description
It was reported that during a training/demo of the da vinci system the customer called to report that repeated non-recoverable fault 802 occurred on bootup.The technical support engineer (tse) had the customer perform hard power-cycle with emergency power off (epo).However, the issue remained.Onsite is not connected at the time.There was no report of patient involvement.

• Brand Name: DAVINCI SI
• Common Device Name: PATIENT SIDE CART, 4-ARM
• 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: 24271205
• Report Number: 2955842-2026-03348
• Device Sequence Number: 10714658
• Product Code: NAY
• UDI-Device Identifier: 00886874110690
• UDI-Public: (01)00886874110690
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K081137
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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: 380614-14
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2015
• 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