MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; MONOPOLAR CURVED SCISSORS

Model Number	420179-23
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The monopolar curved scissors instrument was analyzed and found to have a broken grip cable at the proximal end within the housing.The grip cable was fully broken at the input shaft.There was no discoloration, corrosion, or contamination on the cable to suggest improper reprocessing as a contributing factor.Further inspection revealed no signs of missing parts and found no abnormally sharp or damaged components that could have contributed to the cable breaking.Common causes of broken - proximal instrument grip cables are attributed to damage to the cable during use or during reprocessing.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, only one side of the monopolar curved scissors could be moved.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the customer confirmed that the jaw of the instrument was not static in the open position, and no broken cables were visible at the wrist of the instrument.There were no reports of tissue injury caused by the instrument¿s jaws, and no material was found missing or detached.Additionally, no photographic or video evidence was provided.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: MONOPOLAR CURVED SCISSORS
• 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 ; 4085232100
• MDR Report Key: 24706772
• Report Number: 2955842-2026-18701
• Device Sequence Number: 10439459
• Product Code: NAY
• UDI-Device Identifier: 00886874111505
• UDI-Public: (01)00886874111505(10)K10241121
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: 420179-23
• Device Catalogue Number: 420179
• Device Lot Number: K10241121 283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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