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

Model Number	380747-41
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	08/21/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
There were two procedures identified for the event date.Review of the system logs found no errors during either procedure.Review of the system logs from five subsequent procedures performed on the system also found no errors.An intuitive surgical medical safety officer (mso) reviewed the event and concluded that the patient in this report died following a robotic procedure in which the patient had a post-operative complication of an incarcerated hernia from a port site.While the port sites are used for the robotic procedure, these sites need to be closed after surgery with a surgical process that does not include the use of the robot.Based on the information provided in the summary of events, no intuitive surgical product or instrument contributed to this event.
Event or Problem Description
It was reported that following a da vinci-assisted hiatal hernia procedure, the patient developed an incarcerated trocar-site hernia and subsequently expired.On postoperative day five, the patient presented to the emergency room, where the hernia was identified and an unspecified subsequent procedure was performed.The cause and date of death, as well as additional details regarding the events leading to the death, were not provided.Attempts to obtain additional information from the surgeon and site were unsuccessful.

• Brand Name: daVinci 5
• Common Device Name: Patient 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: 50948206
• Report Number: 2955842-2026-40396
• Device Sequence Number: 21220518
• Product Code: NAY
• UDI-Device Identifier: 00886874119716
• UDI-Public: (01)00886874119716
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 380747-41
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2024
• 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: Death; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female