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

Model Number	478090-03
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the da vinci product to perform failure analysis.The permanent cautery hook (pch) instrument was analyzed and found the instrument was confirmed to fail the continuity test.The housing was removed and the conductor wire was lightly tugged.The wire appeared to be intact at the proximal end.The main tube was disconnected from the chassis and distal end broken.Once the main tube was removed, the broken conductor wire was revealed at the distal end.Thermal damage was observed to the shrink tubing where the conductor wire broke.The probable root cause of a broken conductor wire at the distal end is attributed to component susceptibility to damage through external collisions, during use, or during reprocessing.The probable root cause of thermal damage is typically attributed to conditions during use.
Event or Problem Description
It was reported that during a da vinci-assisted ovarian cystectomy surgical procedure, the single site permanent cautery hook instrument (pch) was found to have defect cautery function.The procedure was completed with no reported patient injury.

• 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: 23043766
• Report Number: 2955842-2025-37691
• Device Sequence Number: 15936964
• Product Code: NAY
• UDI-Device Identifier: 00886874113721
• UDI-Public: (01)00886874113721(11)241017(10)K10241017
• 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: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2025

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: K10241017 0074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2024
• 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: 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