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

Model Number	478090-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 8mm permanent cautery hook (pch) instrument has been returned and evaluated by the failure analysis (fa) team.Fa investigations replicated/confirmed the customer-reported complaint of 'the tip broke'.The instrument was found to have a broken main tube approximately 25mm from the distal tip.The component is broken, and there may be missing pieces, but the size of the missing pieces cannot be confirmed.Components adjacent to this broken main tube do not show damage.Probable root cause is attributed to damage during use, which may result from an accidental drop of the instrument or inadvertent collisions with other instrument excessive side loading on the instrument can also cause the main tube wall to collapse inwards causing it to crack and subsequently break.A review of the provided image was performed by an intuitive surgical, inc.(isi) failure analysis engineer (afe) on 06-nov-2025.The following additional information was provided: image shows a single site pch with the main tube broken at the interface with the tube adapter (tan component).There is not any obvious missing piece.
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, permanent cautery hook (pch) instrument tip was broken.The customer used a backup instrument to continue with the procedure.No fragments fell inside the patient.The procedure was completing as planned with no reported injury.Intuitive followed up with the nurse and obtained the following additional information: the tip of the pch was not detached or broken off.

• 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: 23872954
• Report Number: 2955842-2025-49525
• Device Sequence Number: 5318882
• Product Code: NAY
• UDI-Device Identifier: 00886874113721
• UDI-Public: (01)00886874113721(11)250121(10)K10250121
• 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
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: 478090-03
• Device Catalogue Number: 478090
• Device Lot Number: K10250121 0052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2025
• 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
• Patient Sex: Female