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

Model Number	380614-11
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2026
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.Fse replaced the universal surgical manipulator (usm) to correct the reported problem.The system was tested and verified as ready for use.Isi did receive a da vinci product involved with this complaint to perform failure analysis.The usm was analyzed and found in system logs, the 32056 error was found indicating axes controller arm (aca) in universal surgical manipulator (usm) 2 failed to initialize i2c device on the usm ac 2c axis, confirming the fault occurred in the field.Upon visual inspection, no issues were found that would be related to the reported event.The usm was installed onto a patient side cart fixture test platform (pftp) where usm agc current failed was found to be failing on the ac 2c axis.The complaint was confirmed based on the field evaluation and failure analysis, which indicates that the device may have contributed to the customer reported issue.The probable root cause can be attributed to the yaw searchlight sensor assembly.
Event or Problem Description
It was reported that prior to starting a da vinci assisted surgical procedure, system was checked and persistent error code 32056 was observed on universal side manipulator (usm) arm 2.Troubleshooting was performed via power cycle and hard reboot; however, the issue persisted.Tse advised to disable usm arm 2.Surgeon elected not to disable usm arm 2.The planned procedure was continued under current condition using same system.No report of patient injury.It was further reported that upon completion of the procedure, system was checked and it was indicated that the error fault on usm arm 2 remained persistent.
Additional Manufacturer Narrative
The root cause is attributed to a faulty yaw searchlight sensor causing communication issues within the usm2.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 24508760
• Report Number: 2955842-2026-15049
• Device Sequence Number: 9960364
• Product Code: NAY
• UDI-Device Identifier: 00886874110690
• UDI-Public: (01)00886874110690
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081137
• 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,Followup
• Report Date (Section B): 05/29/2026

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: 380614-11
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2013
• 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