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

Model Number	20300101
Medical Device Problem Codes	Device Stops Intermittently (1599); Insufficient Information (3190)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	03/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the user has declined to return the nanoknife system (sn (b)(4)) involved in the incident to the manufacturer for assessment and repair at this time.Attempts are being made by angiodynamics to obtain additional information in regards to the event.An investigation into the root cause for the event is currently in process.A review of the service history was performed for the serial number (b)(4).The review confirms that the unit met all material, assembly, and performance specifications.The results of the unit evaluation will be sent via a follow up medwatch.Complaint # (b)(4).Device is not available for return.
Event or Problem Description
As reported (b)(6) 2016, a patient of unknown age and gender presented for an ire (irreversible electroporation) procedure.It was reported that during the procedure, the nanoknife system shut down multiple times.The unit was restarted and the procedure was resumed each time.There was no report of harm or injury to the patient due to the event.As there was a delay in the procedure, the patient was assumed to be under anesthesia for an extended period of time.It was reported the customer declined to return the nanoknife system for assessment and repair at this time.
Additional Manufacturer Narrative
The nanoknife generator (sn (b)(4)) was returned for evaluation and repair.The unit returned with a damaged front wheel.No additional damage was noted.The unit was tested per the operational verification procedure and at additional settings to determine if reported error could be duplicated.The reported error could not be duplicated, however, the error log had a recorded failure of the fpga board during the previous use that would suggest the unit had shut down during use.Although the reported fault could not be duplicated during functional testing, the complaint is confirmed based on a review of the unit's error logs.Based on the error logs, the root cause for the unit shutting down was a failure of the fpga board.This was the first repair since the unit was delivered to the account in (b)(6) 2014.The most likely root cause for the fpga board is wear and tear.The fpga board was replaced, and the damaged wheel was realigned.The user manual (nanoknife user manual, 160-105261 rev 01 version 2.2.1), instructs the user to reboot the system to let the auto-test check the system.Repeat any portions of ablation that were not delivered.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 SYSTEM
• Common Device Name: LOW ENERGY DIRECT CURRENT ABLATION DEVICE
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 5573404
• Report Number: 1319211-2016-00056
• Device Sequence Number: 800724
• Product Code: OAB
• Combination Product (Y/N): N
• PMA/510(K) Number: K102329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2016

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
• Operator of Device: Physician
• Device Model Number: 20300101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2016
• Supplement Report FDA Received Date: 01/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1