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

Model Number	380652-53
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted procedure, following anesthesia and prior to port placement, the customer experienced recurrent recoverable errors 1105 and 1162 on universal surgical manipulator (usm) arm#4.Upon reviewing the logs, the intuitive surgical inc.(isi) technical support engineer (tse) determined that usm#4 was faulty and required replacement.The tse guided the caller to disable arm#4 and advised proceeding with the three remaining arms, which the customer indicated would most likely be sufficient for the upcoming procedure.However, the case was ultimately converted to open surgery.No patient injury was reported as a result of the issue or the conversion.
Additional Manufacturer Narrative
An intuitive 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.Fse replaced the universal surgical manipulator(usm)#4.The system was tested and verified as ready for use.

• 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: 50942417
• Report Number: 2955842-2026-40386
• Device Sequence Number: 10740005
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other,Notification
• 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: 380652-53
• Device Catalogue Number: 380652
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 04/11/2022
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: ISIFA2023-07-C
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: da Vinci Instruments and Accessories.
• Patient Sex: Unknown