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

Model Number	380652-51
Medical Device Problem Codes	No Device Output (1435); Visual Prompts will not Clear (2281)
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 the universal surgical manipulator (usm) 1 had a non-recoverable fault 32056 when the system powered on.The customer power cycled the system five times, but the issue remained.The intuitive surgical, inc.(isi) technical service engineer had the customer hard power cycle the system, but the error returned again.There was no report of patient involvement.Isi contacted the clinical territory associate and obtained the following information: the issue was identified when setting up the operating room (or) in the evening on the 6th to get the system ready for the next day.The two patients (procedures) were cancelled and are being rescheduled.No procedure was going on at the time of the event.The robot was isolated until a field service engineer (fse) was able to go on site.There was no delay involved, just cancellation of upcoming procedures.There was no injury to any patient.The fse resolved the issue on the afternoon of the 7th.Isi contacted the technical support engineer and obtained the following information: with error 32056, the customer could have used the system and proceeded with the procedure.
Additional Manufacturer Narrative
An intuitive surgical, inc.(isi) field service engineer (fse) was dispatched to the customer site to further investigate the reported complaint.The fse was able to reproduce the issue and replaced the universal surgical manipulator (usm) 1.The system was tested and verified as ready for use.As of the date of this report, the usm has not yet been received by intuitive surgical, inc.(isi) for evaluation.

• 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: 50942438
• Report Number: 2955842-2026-40382
• Device Sequence Number: 9498721
• Product Code: NAY
• UDI-Device Identifier: 00886874110720
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• 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: 380652-51
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2022
• 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: 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