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

Model Number	480522-02
Medical Device Problem Codes	Failure to Deliver Energy (1211); Failure to Seal (4070)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted pancreatoduodenectomy surgical procedure, the patient experienced postoperative bleeding and required an angiogram.The initial robotic procedure was completed without any complications.There was no excessive intraoperative bleeding noted.The vessel sealer curved instrument was used on the dorsal pancreatic artery, where the bleeding was identified postoperatively.The vessel was approximately 2mm in diameter.The bleeding was controlled by the angiogram; no further intervention was required, and the patient did not have to be taken back to the operating room.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the vessel sealer instrument for failure analysis evaluation.Vessel sealer instrument logs show the instrument was installed 19 times, with 18 installs on universal surgical manipulator (usm) 3 and one install (6th overall) on usm 4.E-200 energy activation data is available and the data shows 355 seal activations and 4 coag/bipolar activations with this instrument.The 359 total activations were all completed successfully per the logs.Metrics showed 304 successful cuts with 0 exposed blade errors and 0 high impedance seals.Logs did not show any errors that appear to be related to the use of the instrument.

• 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: 24367692
• Report Number: 2955842-2026-04140
• Device Sequence Number: 5214688
• Product Code: NAY
• UDI-Device Identifier: 10886874123369
• UDI-Public: (01)10886874123369(10)U10250716
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/17/2026

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: U10250716 0143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2025
• 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
• Patient Sex: Unknown