MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI 5; VISION SIDE CART

Model Number	380746-46
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	03/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An isi field service engineer (fse) was dispatched to further investigate the customer reported issue.The fse reviewed the logs and found some errors from the event date; however, they had cleared after a few power cycles the same day.The fse checked the fiber cables and they were reportedly good.The fse ran light level tests and signals were strong.The fse power cycled the system 8 times with 2 test drives and had no issues.
Event or Problem Description
It was reported that during a da vinci-assisted malignant hysterectomy procedure, the customer was encountering non-recoverable system errors.An intuitive surgical, inc.(isi) technical support engineer (tse)) was unable to review the system logs since the system was not connected to the internet.Before calling the tse for assistance, the customer had already reseated all fiber cable connections except at the console.The tse then guided the customer to power the system off and reseat the console fiber cable.After this, the system powered back on without error, and the customer noted it had previously powered up normally before failing again.The tse remained on the line for several minutes to monitor whether the error would recur while ports were being placed, during which time the surgeon decided to convert the procedure to open surgery due to frustration with the repeated error.No complications to the patient were reported following the conversion to open surgery.

• Brand Name: DAVINCI 5
• Common Device Name: VISION 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 ; 4085232100
• MDR Report Key: 24932105
• Report Number: 2955842-2026-21583
• Device Sequence Number: 5179488
• Product Code: NAY
• UDI-Device Identifier: 00886874119662
• UDI-Public: (01)00886874119662
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K232610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 380746-46
• Device Catalogue Number: 380746
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2025
• 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: Required Intervention
• Patient Sex: Unknown