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

Model Number	380620-41
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/18/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient underwent a da vinci-assisted inguinal hernia repair procedure, expired on postoperative day #1.The cause of death is currently unknown.Additional information was requested, but the customer did not respond to the follow-up questions.However, the customer indicated that the patient¿s death was unrelated to the robotic "grippers".
Additional Manufacturer Narrative
Insufficient information is available for procedure verification; therefore, no da vinci system or instrument logs are available for review.A review of the event performed by an intuitive surgical medical safety officer (mso) concluded that the patient in this report died following a robotic inguinal hernia repair.The cause of death and the details of the events that led to the death are not provided.Based on the information provided in the summary of events, insufficient information is available to determine if any intuitive products or instruments contributed to this event.

• Brand Name: daVinci X
• 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: 50289922
• Report Number: 2955842-2026-36028
• Device Sequence Number: 9705500
• Product Code: NAY
• UDI-Device Identifier: 00886874115404
• UDI-Public: (01)00886874115404
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K171294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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: 380620-41
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2020
• 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
• Patient Sex: Unknown