MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SINGLE-SITE; PERMANENT CAUTERY HOOK

Model Number	478090-03
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a da vinci-assisted ovary cystectomy procedure, the tip of the permanent cautery hook (pch) instrument detached and came out while being removed from the robotic arm.The procedure was completed.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the instrument was inspected prior to use and no damage or anything out of the ordinary was observed at that time.During the surgical procedure, specifically during instrument removal, a device fragment fell inside the patient.However, the surgeon did not notice any issues with the functionality of the instrument during the operation, and there were no collisions with other instruments or hard materials.All fragments were retrieved and this was confirmed through visual inspection by the surgical team.No additional surgical procedure was required to remove the fragment, and no post-operative tests, such as an x-ray or ultrasound, were performed to check for remaining fragments.The entire procedure was completed robotically, and there was no injury to the patient as a result of this event.
Additional Manufacturer Narrative
The permanent cautery hook (pch) instrument has not been received for failure analysis evaluation.
Additional Manufacturer Narrative
Device evaluation: intuitive surgical, inc.(isi) received the permanent cautery hook (pch) instrument to perform failure analysis.The instrument was analyzed and found to have a broken proximal clevis.The broken proximal clevis is not attached to the main tube but returned with the instrument.No missing fragments.Due to the broken clevis, these additional failure occurred: the instrument was found to have a broken conductor wire at proximal clevis additional to the broken clevis.The instrument failed the electrical continuity test.No signs of thermal damage were observed.Also the instrument was found to have various scratches on the main tube.The scratches measured approximately 3.70 mm and 2.75 mm in length and were not axially aligned with the tube axis.The component was damaged and there may be missing pieces/material, but the size of the missing pieces could not be confirmed.The instrument was unable to be tested due to the physical damage condition.
Event or Problem Description
Refer to h11 for follow-up information.

• Brand Name: SINGLE-SITE
• 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: 24424438
• Report Number: 2955842-2026-04250
• Device Sequence Number: 20318051
• Product Code: NAY
• UDI-Device Identifier: 00886874113721
• UDI-Public: (01)00886874113721(11)250102(10)K10250102
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K152448
• 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,Followup
• Report Date (Section B): 04/28/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 478090-03
• Device Catalogue Number: 478090
• Device Lot Number: K10250102 0099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown