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

Model Number 20300101

Device Problem Unexpected Shutdown (4019)

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

Event Date 05/12/2020

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

It was reported that during an ire (irreversible electroporation) procedure using the nanoknife generator on a patient's 3rd tumor, the nanoknife shut down and would not reboot to finish the treatment.Multiple reboots were performed as well as reconnection of the cables and checking of the pins and connections, with no improvement.The following message displayed on the screen: "failure of self-test charge/discharge." ultimately, the procedure was aborted and will be rescheduled, if imaging of the tumor determines the need.As the patient was reported to have been under anesthesia for a prolonged period greater than 30 minuted due to the event, this event meets the criteria of a reportable adverse event.It was reported that the patient suffered no adverse effects due to the event.The customer has requested the facility's unit be evaluated by the manufacturer.

Manufacturer Narrative

Returned for assessment was nanoknife unit (sn (b)(6)).Assessment and testing of the unit determined the failure to self-test was due to a faulty gome board.The most likely root cause of the gome board failure is wear and tear.The reported complaint description of the unit malfunctioning during a procedure, causing the procedure to be aborted (no patient treatment provided) is confirmed.The gome board was replaced, and the unit was tested with no issues noted.After repair the unit functioned as intended during assessment/routine service.A review of the device history records (service order system) was performed for the reported serial number 03111016 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, 160-105261-21), which is supplied to the user with this unit contains the following statements: "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 trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

• Brand Name: NANOKNIFE GENERATOR
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS, QBY; 603 queensbury avenue; queensbury, ny
• MDR Report Key: 10111505
• MDR Text Key: 202391049
• Report Number: 1319211-2020-00034
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 05/12/2020
• Supplement Dates FDA Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR