MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC EndoWrist; PERMANENT CAUTERY HOOK

Model Number	470183-19
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the staff noticed smoke coming from the plastic housing unit of the permanent cautery hook instrument.Staff clearly noted smoke was coming from the housing unit and not the tip of the instrument.They removed the instrument and they said you could smell burnt plastic.The procedure was completed with no reported injury.Isi followed up with the initial reporter and obtained the following additional information: no arcing observed during the last procedure in which the instrument was used.There was no injury to the patient.Smoke was not coming from the tip.The product has already been shipped back to isi for evaluation.No photographic images of the instrument available for review.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The permanent cautery hook instrument was analyzed and found to have thermal damage on the monopolar yaw pulley at the distal end.Material appears to have burned off from the charring that occurred near the yaw hook/spatula.The instrument passed the electrical continuity test.The instrument passed the energy delivery test on 3 out of 3 attempts.During the energy delivery test, smoke came from the yaw pulley due to the thermal damage.Visual inspection found no damage to the conductor wire or its insulation.

• Brand Name: EndoWrist
• 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 ; +1(408)523-2100
• MDR Report Key: 50813716
• Report Number: 2955842-2026-39270
• Device Sequence Number: 16130589
• Product Code: NAY
• UDI-Device Identifier: 00886874112311
• UDI-Public: (01)00886874112311(10)K10260527
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K131861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 470183-19
• Device Catalogue Number: 470183
• Device Lot Number: K10260527 0068
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2026
• 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 Age: 19 YR
• Patient Sex: Female
• Patient Weight: 158 LB
• Patient Race: White