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

Model Number	20300101
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported an end user experienced an issue when using a nanoknife 2.2 generator.At the start of the procedure, the patient was sedated and the needle was placed.When attempting to start applying energy by stepping on the foot pedal, the system was not able to recognize the foot pedal, so they were not able to deliver the energy.They thought it was possibly due to the foot pedal was no longer functioning or the foot pedal connector into the generator was not functioning.The procedure was unable to be performed and therefore aborted.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 device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
The unit and footpedal were not returned for service/evaluation because the service partner of the distributor cleaned the foot pedal.The unit and foot pedal is now functioning as intended.The reported complaint description is not definitively confirmed.The unit and footswitch were not returned for evaluation/repair because a service partner of the distributor cleaned the footswitch.The unit and footswitch were deemed to be working.The root cause for the footswitch not recognized was unable to be determined because the unit and footswitch were not returned for evaluation/service.A review of the device history records (service order history) was performed for the reported serial number (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.Labeling review: the user manual (nanoknife user manual, 160-105261-21) states "the system incorporates a double trigger foot pedal system that prevents accidental delivery of procedure pulses.The foot pedals require the user to first arm the system by depressing the "arm" foot pedal, and then sequentially, depressing the "pulse" foot pedal within 10 seconds of arming to deliver energy to the patient.".Note: the double foot pedal is an essential part of the nanoknife® system.It is graded ipx-8.It is required to use only genuine parts supplied by the nanoknife's manufacturer or authorized distributor.Section 8.2 documented problems and solutions states: "malfunction: cannot arm or activate ablation deliver - possible reasons: foot pedal not properly attached to generator - check all foot pedal connections or damaged foot pedal - call angiodynamics hardware service.".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: 21700168
• Report Number: 1319211-2025-00012
• Device Sequence Number: 8663780
• Product Code: OAB
• UDI-Device Identifier: H787203001010
• UDI-Public: H787203001010
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K150089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: 20300101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 63 YR
• Patient Sex: Male