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

Model Number	380620-48
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Liver Failure (4492); Metabolic Acidosis (4923)
Date of Event	07/11/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient who underwent a da vinci-assisted hepatic lobectomy procedure, developed post-hepatectomy liver failure and expired.The patient was child-pugh class a.There were no intraoperative complications, and the procedure was successfully completed robotically.The surgery involved parenchymal resection, described as approximately 10% non-anatomical resection.The suspected cause of deterioration was portal vein thrombosis that progressed to ischemic hepatitis, accompanied by refractory acidosis and a rising international normalized ratio (inr).Despite intensive care unit level support and other unspecified interventions, the patient expired on postoperative day 2.Attempts were made to obtain additional information from the surgeon; however, no additional information was received.
Additional Manufacturer Narrative
Review of the intraoperative system logs found the system functioned normally with no errors logged and no indications relating to this event.Log review of the 5 subsequent procedures found the system functioned normally; no intraoperative events or issues found.The following concomitant products were used during this procedure: 30 degree endoscope plus, monopolar curved scissors, large needle driver, cadiere forceps, and mbf.A site history review found no complaints were made for the instruments used during this procedure.A review of the event performed by an intuitive surgical medical safety officer (mso) concluded that the patient in this report died following a hepatic resection secondary to portal vein thrombosis in the setting of coagulopathy, acidosis, and class a cirrhosis.How this portal vein thrombosis occurred is not provided.No intraoperative complications were reported.Based on the information provided in the summary of events, insufficient information is available to determine if any intuitive surgical 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: 50211711
• Report Number: 2955842-2026-35375
• Device Sequence Number: 10009280
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: 380620-48
• 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: 07/14/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2025
• 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; Death
• Patient Age: 75 YR
• Patient Sex: Female