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

Model Number	380614-12
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The fse checked error logs and found error 31019 and 31020.The fe checked and noticed that the use hours are reaching maximum limits and updated the counters.The system was tested and verified as ready for use.The complaint was confirmed based on the field evaluation.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the staff contacted the technical support to report a fault.The caller stated that system reported error 31020.Before calling the technical support, site has hard power cycle system for 3 times.But issue remained.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the procedure was converted to traditional laparoscopic surgery.There was no patient injury.
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: 24452645
• Report Number: 2955842-2026-11226
• Device Sequence Number: 9410872
• Product Code: NAY
• UDI-Device Identifier: 00886874110690
• UDI-Public: (01)00886874110690
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/24/2026

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: 380614-12
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2014
• 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