MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PERMANENT CAUTERY HOOK

Model Number	420183-15
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the permanent cautery hook (pch) instrument had no energy output.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
The permanent cautery hook has been returned and evaluated by the failure analysis team.The instrument passed energy delivery testing in various grip orientations.The instrument also passed the electrical continuity test.Based on the investigation results, customer reported issues may be due to other factors unrelated to the product.Additional observation(s) not reported by site: the instrument was found to have thermal damage to various components.The instrument was found to have thermal damage on the monopolar yaw pulley at the cable routing.The conductor wire insulation was found to have thermal damage near the monopolar yaw pulley.The instrument was found to have thermal damage at the distal idler pulley.The instrument was found to have thermal damage on the distal clevis near the idler pulley pin.The instrument was found to have thermal damage on the proximal clevis surface.The probable root cause of the thermal damage is primarily attributed to the use conditions.Clinical use of monopolar energy can also result in thermal damage if the lowest power or effect setting possible is not used for the minimum time necessary to achieve the desired effect.Conductor wire management issues can result in damage to the conductor wire, which may allow a possible arc path during air firing.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PERMANENT CAUTERY HOOK
• 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: 24880803
• Report Number: 2955842-2026-21573
• Device Sequence Number: 21306627
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)N10210531
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/14/2026

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: 420183-15
• Device Catalogue Number: 420183
• Device Lot Number: N10210531 092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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