MAUDE Adverse Event Report: ANGIODYNAMICS NANOKNIFE; LOW ENERGY DIRECT CURRENT THERMAL ABLATION SYSTEM

Model Number	20300301US
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The result of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
A distributor reported an end user experienced an issue when using a nanoknife 3.0 generator.Before the unit was turned on for the procedure, the patient was intubated.They then tried to boot up the unit in the or room, but the system was down.They then smelled a strong smoking, burning odor.The procedure was not continued due to this event.This event has been assessed as a reportable due to patient safety risk, as the patient was under anesthesia and treatment was not completed.
Additional Manufacturer Narrative
The nanoknife unit, serial number (b)(6), was serviced in the field.The reported complaint description is confirmed.When the unit was turned on, smoke was observed coming from the power supply.Yellowish water was accumulated beneath the input power supply.The origin of the water is unknown.The input power supply was replaced.The root cause for the burning smell was determined to be caused by water accumulating beneath the power supply.The input power supply was replaced.This is the first reported error of this unit for burning smell.This is the first time the input power supply has been replaced.The unit was tested with the input power supply per (b)(4) functional test and (b)(4) electrical safety test and met all acceptance criteria.A review of the device history records (service order history) was performed for the reported serial (b)(6) for any deviations related to the reported failure mode of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution, i.E.No ncr associated with reported failure mode.This unit has had no previous complaint related service orders performed.Labeling review: per current user manual 16795933-21, rev.A (page 18): section 5: system operation 5.1 procedure overview an overview of a typical nanoknife ablation procedure is listed below.Refer to subsequent sections of this user manual for detail usage instruction on operation of the nanoknife generator.5.1.1 procedure setup (before patient enters procedure room): 1.Plug in the nanoknife generator and cardiac gating device into a grounded power outlet within the procedure room.2.Power on the nanoknife generator.The nanoknife generator will initiate and complete a power-on self-test (post).3.Attach the double pedal footswitch to the nanoknife generator.5.1.2 patient preparation 4.Prepare patient for general anesthesia.5.Position patient into appropriate position for anticipated nanoknife single electrode probe insertion (e.G., supine, prone, lateral, lithotomy)."maintenance should be carried out only by trained personnel.The generator must undergo periodic preventative maintenance as specified in the maintenance and service (section 9).Avoid moving the device when powered on.Avoid jarring the equipment during transport.System location: the generator must be installed and operated in an environment that conforms to the operating conditions specified in section 10.4.The generator must be installed on rigid surfaces suitable to withstand its weight.Maintenance calibration required every 12 months by an authorized service agent." a review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: NANOKNIFE
• Common Device Name: LOW ENERGY DIRECT CURRENT THERMAL ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 21304097
• Report Number: 1319211-2025-00016
• Device Sequence Number: 15458794
• Product Code: OAB
• UDI-Device Identifier: H78720300301US0
• UDI-Public: H78720300301US0
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K183385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: 20300301US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown