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

Model Number	480422-03
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Tissue Injury (4559)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted right hemicolectomy surgical procedure, while using the vessel sealer extend (vse) instrument, the instrument was not sealing and gave an error indicating a non-complete sealing cycle.Tissue was adhered to the instrument which caused tissue damage and bleeding.Tissue was never cut that was not fully sealed and the instrument was noted to work ¿sometimes¿ with audible tones.The procedure was converted to laparoscopic with no additional ports placed.Information surrounding how the patient tolerated the change in surgery was not known.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did not receive the vessel sealer instrument to perform failure analysis.A field service engineer (fse) also replaced the e-200 generator due to the issue.Vessel sealer logs show this vessel sealer extend (vse) was installed two times on universal surgical manipulator (usm) arm 2 and one time on usm arm 4.The instrument was used for approximately 42 minutes.E-200 activations logs were unavailable.

• 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: 50914741
• Report Number: 2955842-2026-40096
• Device Sequence Number: 17485290
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(11)251211(10)K15251212
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K173337
• 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: Notification,Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: K15251212 0355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2025
• 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: 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