MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC daVinci Xi; VISION SIDE SYSTEM

Model Number	381121-19
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that universal surgical manipulator (usm) 2 faulted with error 32056 while the site's clinical sales representative (csr) was troubleshooting video issues.The intuitive surgical inc technical support engineer (tse) reviewed the system logs and confirmed the reported error.The tse had the csr perform a hard reboot, with no change.The caller stated that the site has several cases scheduled for the following day that they would need all 4 usms for.There were no reports of patient involvement.
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 went on-site and replaced the universal surgical manipulator (usm) 2.The system was verified and ready for use.Intuitive surgical, inc.(isi) has received the unit; however, failure analysis is still ongoing.Additional information is being gathered to determine the contribution of the device to the customer reported issue.

• Brand Name: daVinci Xi
• Common Device Name: VISION SIDE SYSTEM
• 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: 50942414
• Report Number: 2955842-2026-40375
• Device Sequence Number: 18826341
• Product Code: NAY
• UDI-Device Identifier: 00886874110898
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 381121-19
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2016
• 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