MAUDE Adverse Event Report: ANGIODYNAMICS, INC. NANOKNIFE; NANOKNIFE DISPOSABLE SINGLE ELECTRODE PROBE

Model Number	20400109
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective 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 angiodynamics territory manager reported an issue with a 15 cm ire single activation electrode.During the 3rd ablation of a desmoid treatment, one probe started arcing, past the skin, while still inserted in the patient.The previous 2 ablations done with this device were successful with no issues.This only occurred while that probe was in active use, and was quickly shut down after just a few pulses.The physician then removed that probe and completed the ablation with the unaffected probes.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.
Additional Manufacturer Narrative
Correction: d2a the customer's reported complaint of probe sparked was able to be confirmed during evaluation of the returned probe; insulation was damaged.No manufacturing non-conformance was observed, which supports the event description of probe was utilized for two (2) ablation cycles prior to the sparking issue.Engineering evaluation: confirmed reported failure.Connected the device to a hypot tester and the probe failed every time trying new positions.There is damage to the outer insulation close to the tip that is allowing the device to arc.There was some kind of damage caused to the insulation.It is not possible to determine when the damage was caused.After assembly all devices are hypot tested.This defect would be caught during that testing.This device likely was damaged from the end to 3rd ablation of the desmoid treatment.The device would have arced during the first two ablations.Potential root cause for the electrical arcs (spark) observed is use of clamps on the probe needle.Dfu for the nk probes states the following: "do not attach anything to the device unless it is supplied by angiodynamics and indicated for use with this device.Attachments may damage the insulation and contribute to patient injury." a review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the directions for use (dfu) that is supplied with the nanoknife probe contains the following statements: warnings: do not use a device with damaged insulation.Do not attach anything to the device unless it is supplied by angiodynamics and indicated for use with this device.Attachments may damage the insulation and contribute to patient injury.Avoid having the nanoknife single electrode probes touch when delivering pulses.Ensure that both nanoknife single electrode probe electrodes are fully embedded within the targeted tissue prior to initiating pulse delivery.Do not attach anything to the device unless it is supplied by angiodynamics and indicated for use with this device.Attachments may damage the insulation and contribute to patient injury.Placing a single electrode probe without continual image guidance may increase the risk of unintended mechanical perforation, damage to critical anatomical structures, and/or unintended tissue destruction.Imaging equipment with high-definition capabilities is recommended for procedures where a target area involves or is adjacent to critical structures.Having inadequate imaging equipment may result in unintended mechanical perforation, damage to critical anatomical structures, and/or hemorrhage.Potential adverse effects adverse effects that may be associated with the use of the nanoknife system include, but are not limited to: arrhythmia, atrial fibrillation or flutter, tachycardia,fistula formation, damage to critical anatomical structure,(nerve, vessel, duct) hemorrhage, muscle contraction.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: NANOKNIFE DISPOSABLE SINGLE ELECTRODE PROBE
• 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 ; 8007726446
• MDR Report Key: 23076478
• Report Number: 1319211-2025-00039
• Device Sequence Number: 9719468
• Product Code: OAB
• UDI-Device Identifier: H787204001090
• UDI-Public: H787204001090
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: 20400109
• Device Lot Number: 5849603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown