MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC daVinci 5; Surgeon Side Cart

Model Number	380730-50
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2026
Type of Reportable Event	Other
Event or Problem Description
It was reported that during a da vinci-assisted malignant hysterectomy procedure, the left hand master tool manipulator (mtm), failed on the surgeon side console (ssc), prompting the customer to contact an intuitive surgical, inc.(isi) technical support engineer (tse) for assistance.Prior to reaching out, the surgeon had already removed the instruments from the patient and universal surgical manipulators (usm), and performed a mid-procedure restart.However, the issue persisted.Upon engagement, the tse confirmed error codes pointing to the left mtm based on a review of the logs and guided the customer through an additional power cycle, which included switching the ssc breaker to off.The blue fiber cable was verified to be seated correctly, and the customer turned the breaker back to on.Although the system initialized successfully, the fault condition remained unchanged, with on-screen prompts offering options to either restart or disable the left manipulator.A further restart was attempted by the tse, but the issue continued without resolution.The customer stated that, as an alternate da vinci system was not available, the case was converted to an alternative surgical procedure.However, it is unclear if the procedure was converted to open surgery or traditional laparoscopic surgery.As a result of the conversion, sentinel node collection from the left side was not performed; however, no injury to the patient was identified as a result of the issue or the conversion.The patient tolerated the conversion well.The issue occurred approximately 40 minutes into the procedure, and the patient did not experience any post-operative complications.
Additional Manufacturer Narrative
An 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 replaced the left mtm.The system was tested and verified as ready for use.

• Brand Name: daVinci 5
• Common Device Name: Surgeon Side Cart
• 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: 50855446
• Report Number: 2955842-2026-39397
• Device Sequence Number: 9652023
• Product Code: NAY
• UDI-Device Identifier: 00886874119747
• UDI-Public: (01)00886874119747
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K232610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 380730-50
• Device Catalogue Number: 380730
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2025
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: da Vinci Instruments and Accessories.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown