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

Model Number 20300101

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2020

Event Type  malfunction  

Manufacturer Narrative

The reported nanoknife unit has yet to be returned to the manufacturer for assessment.An investigation into the root cause for reported event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

An angiodynamics territory manager reported the following: "during the ire opening procedure in (b)(6) hospital on (b)(6) 2020, the patient had been anesthetized and been put on the ecg electrode patch.Patient abdomen was open.Three probes have also been inserted into the patient's pancreas, and ready to release energy.After the device sn (b)(4) was charged, the foot pedal could not trigger the electric pulse.Before the ire procedure, the device has passed the self-test, and acton engineer did not find anything abnormal in the twice boot up inspections, and also did not find any breakage in the appearance of the foot pedal and the wire connector.After the foot pedal failed to trigger, the engineer tried to reboot the device and reconnect the foot pedal, but three attempts failed.The fourth time, we contacted angiodynamics' engineer (b)(6), at her suggestion, the engineer used alcohol to carefully clean the foot pedal connector and the device end interface, and then reconnected the pedal but it did not work the patient was immediately closed.Finally, engineer (b)(6) assessed the foot switch was failed and unable to finish the procedure, and the procedure was aborted.It was indicated the reported nanoknife generator is available for return to the manufacturer for a device evaluation.This event meets the criteria a reportable adverse event; patient safety risk as treatment was not provided, but patient had been sedated.

Manufacturer Narrative

A field service was provided for nanoknife unit, sn (b)(6).After troubleshooting, the fault was found to have originated in fpga board, not the foot/pedal switch as originally reported.The fpga board was replaced and the unit passed all testing.The reported complaint description is confirmed.The root cause for the malfunction of the unit was determined to be a defective fpga board, which was replaced.This is the first reported error of this unit for malfunctioning.This is the first time the fpga board has been replaced.The most likely root cause of the fpga board failure is wear and tear.The unit was tested with the new fpga board per functional testing and electrical safety testing and met all acceptance criteria.A review of the device history records (service order system) was performed for the reported serial number 02490914 for any deviations related to the reported defect of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution.Labeling review: the user manual states: "the operating system will automatically begin its start-up process and self-checks.It will run through the following self-checks before the user is able to begin the procedure process: initializing device, checking connections, checking status, checking memory, device setup, testing charge, test delivery", "a screen will display each check's progress until the generator completes the start-up self-test and all checks pass successfully", "if one of the generator's self-tests fails, an error message will be displayed.Figure 4.2.3 is an example of an error message.The user must then click ok, which will shut down the generator, so that it can be restarted.If all self-tests are successful, the information screen (see figure 5.1.1) then appears next on the lcd display", and "troubleshooting: message: error fpga recognition self-test failed.Check that the red stop button is depressed and reboot the system.Possible reasons: red stop button is depressed.Actions: check the red stop button status indicator (green light).It should be lit.If not, twist the button clockwise slightly and release the button.The red stop button indicator should be on".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 SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 11074251
• MDR Text Key: 223720441
• Report Number: 1319211-2020-00088
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20300101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR