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	Insufficient Information (4580)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted benign hysterectomy surgical procedure, the vessel sealer extend instrument did not work while inside of the patient.The customer was unable to open the jaws.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the vessel sealer extend instrument to perform failure analysis (fa).The instrument was found to have a dislodged backend pulley at the proximal end housing.This causes rattling in the housing.The pulley is detached from its original position and loosely placed inside the housing.As a result, the grip cable became loose.The jaws do not open and close properly upon testing.Additional observation related to customer reported complaint was that the instrument was found to have loose grip cables in the proximal end.The cables are loosely placed around the clamping pulleys.This caused the jaws not to open and close properly.This is caused by the dislodged back-end pulley.The instrument exhibited imprecise motion during gripping and un-gripping.The instrument was placed on an in-house system and 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.The probable root cause of the imprecise motion is attributed to the dislodged backend pulley and the loose grip cable.The probable root cause of the dislodged backend pulley is attributed to component susceptibility to damage per usage-related conditions.

• 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: 50204342
• Report Number: 2955842-2026-35244
• Device Sequence Number: 21401237
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)K12260313
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/10/2026

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: K12260313 0253
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2026
• 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: Female