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	05/29/2026
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 instrument was not working.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The vessel sealer extend instrument was analyzed and found to have a grip ring screw dislodged.The grip ring screw was found attached to the magnet inside the housing.Also, the instrument was found to have the grip open ring dislodged at the proximal end.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.As a result of the grip ring screw dislodged, the grip ring also became dislodged.The instrument was found to have a dislodged blade.Visual inspection showed that the blade was extended 2.48mm outside of the blade garage.Components adjacent to this dislodged blade show damage.The grip ring screw and grip ring were found to be dislodged inside of the housing.The instrument was placed on an in-house system and passed engagement but failed initialization test on 3 out of 3 attempts.No logs displayed during review since the instrument was used on dv5 system.Lastly, the instrument was returned with the power cord cut off.Visual inspection did not reveal any thermal damage or signs of melting.The complaint was confirmed by failure analysis.The probable root cause is attributed to improper tightening of the set screw into the threaded hole of the grip ring during the manufacturing assembly process.

• 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: 50212406
• Report Number: 2955842-2026-35389
• Device Sequence Number: 9998505
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(17)271231(10)K15251221
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 08/11/2026

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: K15251221 0239
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/27/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2025
• 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
• Patient Sex: Unknown