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); Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive the permanent cautery hook instrument to perform failure analysis (fa).Fa was able to confirm and reproduce the customer reported complaint.The instrument was found to have thermal damage on the monopolar yaw pulley at the distal clevis.Material appears to have burnt off from the charring that occurred near the distal clevis.The instrument failed the electrical continuity test.Components adjacent to the yaw pulley do not show thermal damage.A regulatory post market surveillance analyst reviewed the photo the customer submitted, and the photo was consistent with the alleged complaint of burn marks on the instrument's tip.No further escalations are required for the image review.The probable root cause of the thermal damage is primarily attributed to the use conditions of monopolar energy if the lowest power or effect setting possible is not used for the minimum time necessary to achieve the desired effect.If this instrument has thermal damage but no damage to the conductor wire and/or ceramic sleeve, then this damage is the result of capacitive coupling, which is the transfer of electrical energy between two conductive materials that are separated by intact insulation.Capacitive coupling from the distal electrode should be detectable by the user as the distal electrode should always be visualized when energy is activated.
Event or Problem Description
It was reported that after a da vinci-assisted surgical procedure, an abnormal discharge occurred at the head end of the permanent cautery hook instrument.When the instrument was removed, there were burn marks on the tip of the instrument.The procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the arcing occurred at the head in the end of the instrument and there was damage in between the jaws.The issue occurred while cauterizing.The settings on the esu were cut 4 and coag 4.The instrument was in use for 10 minutes.The instrument was in contact with tissue when the arcing occurred.There was no injury to the patient.The instrument was inspected prior to use and no damage was observed.The instrument did not collide with a different instrument and did not touch any staples, clips or sutures when energized.
Event or Problem Description
Refer to h11 for follow-up information.

• 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: 21361647
• Report Number: 2955842-2025-01499
• Device Sequence Number: 18251521
• Product Code: NAY
• UDI-Device Identifier: 00886874111536
• UDI-Public: (01)00886874111536(10)K10230418
• 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,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: K10230418 116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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: Reuse
• 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