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	08/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The single port permanent cautery hook (pch) instrument has been evaluated by the failure analysis (fa) team.Fa was able to confirm/reproduce the reported complaint.The instrument was found to have a broken proximal clevis at the base of the clevis.The broken piece was returned, measuring roughly 0.8950¿ x 0.2170¿ in size.Clevis shows abrasions or scratches on the outer surface.Components adjacent to the broken clevis do not show damage.The probable root cause was attributed to damage during use, which may result from applying excess force on the instrument tip during handling, insertion, usage (overloading), or removal.Instrument collisions with other hand-held instrumentation or instrument driven outside the field of view can also cause damage to the instrument proximal clevis.
Event or Problem Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, the single site permanent cautery hook (pch) instrument was observed to have a broken tip.There were no report of detachment and no report of fragment(s) falling inside the patient.The procedure was completed but the patient outcome was not provided.

• 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: 23901420
• Report Number: 2955842-2025-49685
• Device Sequence Number: 5092637
• Product Code: NAY
• UDI-Device Identifier: 00886874113721
• UDI-Public: (01)00886874113721(11)241031(10)K10241031
• 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: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2025

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: K10241031 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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