MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI ENERGY; VESSEL SEALER CURVED

Model Number	480522-02
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Great Vessel Perforation (2152)
Date of Event	03/23/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The vessel sealer curved instrument is not available for investigation as it is single use and was discarded after the procedure.Review of the intraoperative system logs for the duration of the procedure show the system functioned normally and there were no indications relating to this event.Review of the logs for the five subsequent procedures found the system functioned normally, no intraoperative events or issues were found.Review of the vessel sealer curved logs found that the instrument was used for about 40 minutes with no errors.The e-200 generator activation event logs also found no errors.The following concomitant products were used during this procedure: endoscope 30 degree, prograsp forceps, permanent cautery hook, medium-large clip applier, large suturecut needle driver, fenestrated bipolar forceps, tip-up fenestrated grasper.A site review found that no complaints have been reported for any of the products used.Video from the procedure was provided for investigation.Review of the video by a clinical development engineer found that there was no observed product malfunction related to unexpected energy delivery or excessive thermal spread in the video.The observed pattern of tissue effect following energy activation appeared nominal.There were no observed instances of product malfunctions related to the reported unexpected jaw motion during the video; no instances of the jaws opening in a more rapid or sudden manner than expected were identified.Review of the case video by an intuitive surgical medical safety officer (mso) found several significant bleeding events with visual suggestion of aggressive dissection, excessive tension of major vessels, and energy activation of the vsc without full visualization of the tissue grasped and in close proximity to the aorta throughout the recorded video.The final bleeding event visible on the video begins when the vsc was used near the aorta while a bedside assist laparoscopic suction device was placing what appears to be significant downward traction on the celiac trunk via nearby vessels branching from the celiac trunk.The bleeding becomes further accentuated when placement of a bulldog clamp on the celiac is attempted which appears to further injure the celiac trunk.Based on the available information, no intuitive surgical product or instrument contributed to this event.
Event or Problem Description
It was reported that during a da vinci-assisted median arcuate ligament syndrome release (mals) procedure, the patient experienced intraoperative bleeding from the aorta and ultimately expired.The vessel sealer curved (vsc) instrument was being used for blunt dissection and cautery when significant bleeding occurred from the aorta.The procedure was emergently converted to an open approach.When an assisting vascular surgeon cross clamped the aorta during repair attempts, the patient¿s pulse was lost and chest compressions were started.With no return of a pulse, the cross clamps on the aorta were removed and bleeding continued with the chest compressions.The patient expired in the operating room.The surgeon stated that the cause of the aortic injury was unknown.The surgeon reported that throughout the procedure, it was noticed that the vsc produced increased thermal spread and increased bleeding after energy activation when compared to the vessel sealer extend.It was also stated that the vsc jaw movement would open a little slowly at first, then would spring open quickly, with increased bleeding from the fast jaw opening.No additional information was provided.

• Brand Name: DA VINCI ENERGY
• Common Device Name: VESSEL SEALER CURVED
• 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: 24961585
• Report Number: 2955842-2026-22620
• Device Sequence Number: 17382069
• Product Code: NAY
• UDI-Device Identifier: 10886874123369
• UDI-Public: (01)10886874123369(17)271031(10)U10251031
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K250674
• 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): 04/22/2026

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: 480522-02
• Device Catalogue Number: 480522
• Device Lot Number: U10251031 0060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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 Sex: Male