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

Model Number 20300101

Device Problem Failure to Fire (2610)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the nanoknife system (sn (b)(4)) involved in the incident is available to be returned to the manufacturer for evaluation.The results of the unit evaluation will be sent via a follow up medwatch.Complaint # (b)(4).

Event Description

An end user reported when hitting the "fire" pedal on the double-foot pedal, the nanoknife generator did not activate.Multiple reboots were performed as well as reconnection of the cables and checking of the pins and connections, with no improvement.The end user believes the cause of the failure was likely a loose connection with the foot pedals which then prevented the delivery of treatment and the device was prevented from discharging the treatment energy to the patient.The foot pedal was replaced.Ultimately, the procedure was aborted and rescheduled for a later date.The patient did not experience any adverse effects or harm.As the patient was sedated and treatment was not provided, this event meets the criteria as a reportable adverse event.The customer has requested the facility's unit be evaluated by the manufacturer.

Manufacturer Narrative

The customer determined not to return the reported nanoknife unit for evaluation.A new foot pedal had been sent to the account and it was reported the unit was functioning as intended.As the reported nanoknife unit was not returned, angiodynamics is unable to perform a device evaluation.The reported complaint description could not be confirmed as neither the generator or foot pedal was returned for service/evaluation.The territory manager was contacted to inquire about the unit returning, and they stated the new foot pedal that was sent was working and unit was not returning for service.The root cause for the foot pedal does not activate unit was not able to be determined as the unit was not returned for service.A new foot pedal was sent to the customer and they stated the unit is functioning as intended.A review of the device history records (service order system) was performed for the reported serial number (b)(6) 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 (nanoknife user manual) "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.Complaint reference (b)(4).

• Brand Name: NANOKNIFE GENERATOR
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury, ny
• MDR Report Key: 10111371
• MDR Text Key: 198029407
• Report Number: 1319211-2020-00033
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20300101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other