MAUDE Adverse Event Report: ANGIODYNAMICS, INC. NANOKNIFE; LOW ENERGY DIRECT CURRENT ABLATION SYSTEM

Model Number	20300301US
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
An end user reported an issue with a nanoknife 3.0 generator.During a routine electrical test of the unit, when the unit was turned on, a noise was heard and smoke came out of the air vents.
Additional Manufacturer Narrative
Correction: e3 the unit was initially evaluated in the field by a for medical field service technician.The reported complaint description is confirmed.The unit was opened and the power supply contained 2 blown capacitors.The power supply module was replaced and the unit functioned as intended.The root cause for the "burnt/smoke" was determined to be caused by two blown capacitors in the power supply module, which was replaced.This is the first reported error of this unit for burnt.This is the first time the power supply module has been replaced.The unit was tested with the new power supply module per svc-002-s10 functional test and svc-027 electrical safety test and met all acceptance criteria.A review of the device history records (service order history) was performed for the reported serial number 07040724 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.Labeling review: the user manual (nanoknife user manual, {16755922-21), which is supplied to the user with this unit states: 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 ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 22308172
• Report Number: 1319211-2025-00029
• Device Sequence Number: 12937927
• Product Code: OAB
• UDI-Device Identifier: H78720300301US0
• UDI-Public: H78720300301US0
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 10/30/2025
• 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): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown