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

Model Number	380652-46
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to start of da vinci-assisted surgical procedure, site contacted intuitive technical support engineer (tse) to report error 32056 on universal surgical manipulator (usm) 3 and could not be cleared after restarting the system.I had the customer perform two hard power cycles, but the issue did not recover.Disabling the affected arm was difficult.The procedure was converted to laparoscopic with no reported injury.
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 replaced the universal surgical manipulator (usm).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.However, failure analysis is not complete.

• Brand Name: daVinci Xi
• 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 ; +1(408)523-2100
• MDR Report Key: 50927998
• Report Number: 2955842-2026-40301
• Device Sequence Number: 18831073
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131861
• 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): 09/28/2026

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: 380652-46
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/22/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2019
• 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