MAUDE Adverse Event Report: ANGIODYNAMICS, INC. NANOKNIFE SYSTEM ; LECD THERMAL ABLATION SYSTEM

Model Number 20300101

Device Problems Device Operates Differently Than Expected (2913); Failure of Device to Self-Test (2937)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2014

Event Type  malfunction  

Event Description

As reported on (b)(6) 2014, a patient of unknown age and gender presented for a lecd thermal ablation of the pancreas.The patient was placed under anesthesia while the unit was prepped for the procedure.At the start up of the unit, the unit failed the self-test.As there was a delay in the procedure, the patient was under anesthesia for an extended time.A second nanoknife unit, available at the medical facility, was utilized to successfully complete the procedure.There was no harm or injury to the patient due to the event.It was reported the nanoknife system is available for return for evaluation to the manufacturer.

Manufacturer Narrative

It was reported that the nanoknife unit (sn (b)(4)) involved in the incident is available to be returned to the manufacturer for evaluation.To date the generator has yet ot be returned.Attempts are being made to obtain the device.An investigation into the root cause for event is currently in progress.A review of the device history records 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.

Manufacturer Narrative

Nanoknife unit (sn (b)(4)) was returned for evaluation and repair.During assessment of the returned generator, the unit failed the self-test.Further investigation found that the switching board was defective and that the stop button was inoperable.The reported complaint description was confirmed as the unit did not function as intended.The root cause for the complaint description was determined to be a defective switching board.The switching board was replaced and the stop button was refitted to operate as intended.The generator was tested per operational verification procedure and met all acceptance criteria.A review of the device history records was performed for the serial number (b)(4).The review confirms that the unit met all material, assembly, and performance specifications.The user manual (nanoknife user manual, which is supplied to the user with this unit contains information referencing self-testing and troubleshooting protocols for self test failures.This angiodynamics hardware unit has a related disposable device however the reported complaint could not be related to the disposable device.The nanoknife completes the self-test before it allows the unit to engage with the probe or continue to the next step to start treatment.As reported, there was no harm to the patient due to the delay in procedure.The case was completed with another nanoknife unit without further complications.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.

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LECD THERMAL ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS, INC.; queensbury NY
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury ave.; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave.; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 4289198
• MDR Text Key: 17689144
• Report Number: 1319211-2014-00200
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K080376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• 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?: Yes
• Date Returned to Manufacturer: 07/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2014
• 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