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

Model Number 20300101

Device Problem Charging Problem (2892)

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

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

The nanoknife generator (serial number (b)(4)) has been returned to the manufacturer and an investigation into the root cause for 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 specialist reported an issue with an end user's nanoknife 3.0 generator.There were no noted issues when booting up the unit for the procedure.The end user stated the generator just wouldn't hold a charge.It automatically self-discharged every time it reached 3000v.Initially the charge was not going above 400v and then discharging itself.6 probes had been placed, parameters all set, and the ecg was okay.No conductivity was "test initiated", so the provider changed a "distancevvalue" and then the conductivity test did initiate.However, after this, the charge would go to 3000v and start discharging itself at about 1500v.At this stage, the provider powered down the generator, unplugged it for 30secs and turned it back on.The "calibration test" was satisfactory.The same issue occurred each time they tried to charge.The unit was rebooted, for a total of three times with no change.In between, the provider checked all connections, ensured the stop button not depressed, wiped the touch screen pad, and plugged the unit into a separate electrical source from the navigation system and heating blanket.Due to this event and delay in procedure greater than 30 minutes, the procedure was aborted.Treatment was not completed and rescheduled for (b)(6) 2021.There was no report of the patient experiencing any adverse effects, harm, or require medical intervention as a result of this incident.This event meets the criteria a reportable adverse event; patient safety risk as treatment was not provided, but patient had been sedated.The reported nanoknife generator (serial number (b)(4)) has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.

Manufacturer Narrative

The nanoknife generator (serial number (b)(6)) was returned for evaluation.Unit was functional tested and no repairs were performed because the unit functioned as intended and met all acceptance criteria.No corrections were required.The customer experience with this nanoknife generator during this procedure cannot be definitively determined.The reported complaint description of charge fault is not confirmed.The log files were reviewed by an sme for the software and determined that the reported events could be caused by intermittent ecg signals or a bad signal, cable, connector or loose cable connection at the nk or ecg sync generator.All cables were checked with no noted issues.The unit appeared to function as intended during the operational verification testing.The unit was tested multiple times per functional test and electrical safety testprocessess.The unit met all acceptance criteria.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: self test fails: the user manual, which is supplied to the user with this unit contains the following statements: "the nanoknife generator will begin a start-up self test.It will run through a series of tests before the user gains access to the nanoknife software.If one of the generator's self-test checks fails, an error message will be displayed.Figure 4.2.3 is an example of an error message.The user must then click the proceed button, which will shut down the generator, so that it can be restarted.The nanoknife generator startup self test has failed because of a damaged or faulty component.Note the number listed in parenthesis in the title of the popup.Call angiodynamics hardware service." charge fault: the user manual, which is supplied to the user with this unit contains the following statement: "troubleshooting: the system detected a problem while charging or discharging the capacitors.Click the proceed button, which will close the popup.Click the charge button.The nanoknife generator should charge the capacitors.If the system is not able to charge or discharge the capacitors, 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 SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT 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 ; 5086587805
• MDR Report Key: 12688069
• MDR Text Key: 278102525
• Report Number: 1319211-2021-00076
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• 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: 10/12/2021
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1