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

Model Number 20300101

Device Problem Device Stops Intermittently (1599)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that the nanoknife system ((b)(4) ) involved in the incident is available to be returned to the manufacturer for evaluation.To date, the generator has yet to be returned.Attempts are being made to obtain the unit.The results of the unit evaluation will be sent via a follow up medwatch.(b)(4).

Event Description

As reported to angiodynamics on (b)(6) 2018, the treating physician reported that the irreversible electroporation (ire) generator shut down approximately 5-6 times during an ire procedure.As a result, the treatment is prolonged approximately 90 minutes longer than as normally performed.During this time, the patient is under anesthesia.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.The unit has yet to be returned to the manufacturer for evaluation.

Manufacturer Narrative

The reported nanoknife unit was returned to angiodynamics' facility in (b)(4).Returned with the unit were the foot pedal and power cord.A visual examination of the unit noted it was in good physical condition.During functional testing, several rfid card errors were noted in the unit's logs.This indicated the need to replace the rfid board.The rfid board was replaced, however, when testing the unit, errors still appear in log files and ire shut down.Hardware services replaced the ac-dc board, the switching board, the charging board, and the "gome" board, however errors still appeared.It was determined that the issue was most likely due to a faulty motherboard or from the power supply since these components had not been replaced.As these components are not available to angiodynamics hardware services for replacement, angiodynamics is unable to continue to evaluate the unit.It was determined to return the unit to the manufacturer, igea, for inspection.Evaluation of the unit by igea determined the cmos battery was exhausted.The battery was replaced.Igea reset the bios and restored the bios with correct parameters.During the servicing of the unit, igea also noted the rfid board's sd card was not correctly inserted in it's slot.Igea correctly inserted the sd card.Igea determined the root cause for the unit failure was an exhausted battery and incorrect rfid board sd card.The battery was replaced and the rfid sd card was correctly inserted.The unit was returned to angiodynamics where it was tested.The unit passed all testing.Unit meets all acceptance criteria.A review of the device history records was performed for the (b)(4).The review confirms that the unit met all material, assembly, and performance specifications at the time of manufacture.The user manual, which is supplied to the user with this unit, contains the following statements: "output current restriction: when the generator senses that the current between the electrodes exceeds the operating parameters, the pulses are aborted.This safety feature protects against applying output energy that exceeds maximum current settings.Do not use the generator if a malfunction is suspected.Contact the manufacturer or the local authorized supplier.5.1.1 procedural guidelines: the nanoknife system requires muscle blockade and general anesthesia.0/4 to 1/4 twitches on the train of four test.Asa guidelines require a defibrillator be readily available for general anesthesia (defibrillator pads recommended)." 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.(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: 7305633
• MDR Text Key: 101240564
• Report Number: 1319211-2018-00018
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 20300101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention