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

Model Number 20300101

Device Problems Device Remains Activated (1525); Unexpected Shutdown (4019)

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

Event Date 03/20/2023

Event Type  malfunction  

Manufacturer Narrative

The nanoknife generator (serial number (b)(4)) 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 Description

An angiodynamics clinical specialist reported an issue with a nanoknife 2.2 generator in which she was in attendance.During the last 40 pulses, they received a "low current" error.10 more pulses were delivered, then a "high current" error occurred.At that time, the "emergency stop" pop up error displayed and the machine shut down.The cs rebooted the unit without issue, set it up again to deliver the last 20 pulses, and the unit immediately hit a high current and shut down again.After the second shut down we aborted the case, and the cs did not attempt to turn it back on.After this, once the machine display was black, the generator gave another pulse to the patient (patient's body moved and we heard the pop).The pop was in the patient, and sounded like a regular delivered pulse, and the patient moved as expected during a pulse.There was no burning, smoke, or smell during this time.It happened right as the provider grabbed the probes to pull them out of the patient while the generator was black.It was confirmed the pulse was being delivered without initiation.The cs hit the red emergency button, and no more pulses seemed to occur.The entire procedure was stopped at that time.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.

Manufacturer Narrative

Returned for evaluation was unit serial number (b)(6).The reported complaint description is not confirmed.The log files were forwarded to nanoknife consulting engineer and it was determined the unit functioned as it was designed.The exact steps to shut down the unit before it "discharged a pulse" by the end user is unknown.It is assumed that the user did not follow the proper shut down sequences to ensure all power is discharged before removing the probes.As indicated by the engineer, shutting down the software/top end of the console does not shut down the controller--the only way to do that is to either hit the e-stop (red) button or to switch off the ac power.The nk software cannot directly control the power to the bottom end of the unit.If there is a failure (like the communications failure) during treatment, then the user must press the e-stop button manually as indicated by the graphic on the display.The unit was tested per svc-002-s06 functional test and met all acceptance criteria.So 40028 will manage the final disposition of the unit.There is no indication that this unit cannot be released back into inventory because the unit functioned as intended.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, which is supplied to the user with this unit states: (high current) 5.1.8 high current and over current conditions if the generator detects pulses that exceed the maximum current settings, 50amps, the generator will end the pulse short and prevent the remaining pulses within the 10 from being delivered.This is referred to as an over current condition.After a short amount of time, the generator will attempt to deliver another set of 10 pulses at the same procedure settings.The generator only attempts to deliver each group of 10 pulses unless the abort delivery button is pressed.If the over current condition procedure is not aborted by the user, the status column will display an orange high current status icon.The total number of pulses delivered, below the maximum current settings, are shown in the total pulses delivered column.At the completion of pulse generation when high current is detected, the user has two button options; continue procedure and stop procedure.Selecting the stop procedure button will reset the pulse generation screen, reduce the capacitors' charge to the test pulse voltage, and ready the device.Selecting the continue procedure button will display an action required pop-up screen, as shown in figure 5.1.47, with the following message: adjust voltages for high current segments? selecting the yes button will reduce the voltage setting by 5% of each probe pair and attempt to redeliver any pulses that experienced an over current condition during the initial round of pulse generation.Selecting the no button will keep the same voltage settings and attempt to redeliver any pulses that experienced an over current condition during the initial round of pulse generation.5.1.9.1 emergency procedure interruption to interrupt or stop a procedure, it is sufficient to use the abort delivery button on the pulse generation screen.When the abort delivery button is selected, the generator will stop the procedure and will be able to resume the procedure where it was stopped.To stop a procedure, press the red stop button located on the front panel of the generator as shown in figure 5.1.49.When pressing the red stop button, the generator internally disconnects the energy load and automatically discharges the energy accumulated on the capacitors.After engaging the red stop button to stop delivery of a procedure, it is necessary to do the following: · release the red stop button, by rotating it clockwise, as the arrows on button indicate.· turn the power off at the main switch on the back panel of the generator and then after 10 seconds turn the power back 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
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 16743234
• MDR Text Key: 313729826
• Report Number: 1319211-2023-00055
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

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
• Device Operator: Health Professional
• Device Model Number: 20300101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/14/2023
• Supplement Dates Manufacturer Received: 08/19/2023
• Supplement Dates FDA Received: 08/21/2023
• 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
• Patient Sex: Male