MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC Endowrist; VESSEL SEALER EXTEND

Model Number	480422-03
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	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted total gastrectomy procedure, after sealing with the vessel sealer extend (vse) instrument, unexpected bleeding was observed from the omentum.The amount of blood loss was not provided.No blood transfusions were administered, and the bleeding was controlled using a fenestrated bipolar forceps (fbf) instrument.The procedure was completed.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive a da vinci product to perform failure analysis.Vessel sealer logs showed this vessel sealer extend (vse) instrument was installed 6 times and passed homing 6 times.130 cut complete events were noted.The instrument was used with an e-200 generator and logs show one error: "e-200 energy activation halted by an instrument or instrument cable connected to the blue upper bipolar port on the e-200 generator while sealing with a vessel sealer instrument.¿ the instrument was used for approximately 74 minutes.

• Brand Name: Endowrist
• Common Device Name: VESSEL SEALER EXTEND
• 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: 50897744
• Report Number: 2955842-2026-39861
• Device Sequence Number: 6001541
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)K17260130
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other,Notification
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: 480422-03
• Device Catalogue Number: 480422
• Device Lot Number: K17260130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2026
• 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: ISIFA2022-01-C
• 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