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

Model Number	480422-03
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a davinci assisted surgical procedure, the customer identified that the vessel sealer extend (vse) instrument was defective.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
An investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The vessel sealer extend (vse) instrument was analyzed and failure analysis investigations replicated and confirmed the customer reported complaint.The instrument was found to have a grip ring screw dislodged at the proximal inside of the housing.The grip ring screw was found attached to the magnet inside the housing.Component adjacent to the dislodged grip ring screw show damage.Grip ring was found to be dislodged from its original position.Visual inspection did not find any damage at the distal end.Manual articulation was performed and the instrument grips failed to open and close properly.Additionally, the instrument was found to have the grip open ring dislodged at the proximal end inside of the housing.The set screw became dislodged from the grip ring, causing the grip ring to shift, furthermore affecting the operation of the instrument's jaws.The jaws would not open when attempted.Component adjacent to the dislodged grip ring show damage.Grip ring screw was found to be dislodged from its original position.As a result of the grip ring screw dislodged, the grip ring also became dislodged.The instrument exhibited imprecise motion during gripping and un-gripping.The instrument was placed and driven on an in-house system.The instrument passed the recognition, engagement and initialization tests on 3 of 3 attempts.The grip tips moved within the joint limits and in the commanded direction, however a lag or delay in the motion that was observed.The jaws failed to open properly.

• 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: 50878874
• Report Number: 2955842-2026-39828
• Device Sequence Number: 18814064
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)K15260418
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 480422-03
• Device Catalogue Number: 480422
• Device Lot Number: K15260418 0197
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2026
• 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: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: da Vinci Instruments and Accessories.
• Patient Sex: Unknown