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

Model Number 20300101

Device Problem Device Stops Intermittently (1599)

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

Event Date 09/27/2016

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.To date, the generator has yet to be returned.Attempts are being made to obtain the unit.An investigation into the root cause for the event is currently in process.The results of the unit evaluation will be sent via a follow up medwatch.(b)(4).Device not returned to date.

Event Description

As reported september 29, 2016, a male patient of unknown age presented for an ire (irreversible electroporation) procedure of the kidney.During the procedure, the nanoknife system unexpectedly shut down approximately 3 times.Each time, the unit was restarted and the procedure was resumed.As there was a delay in the procedure due to the unit malfunction, it is assumed the patient was under anesthesia for an extended time.It was reported that the patient suffered no adverse effects due to the event.It was reported the nanoknife system is available for return to the manufacturer for evaluation.

Manufacturer Narrative

The nanoknife generator received field service at the customer site for evaluation and repair.The unit was noted to be in good physical condition.A review of the log files confirmed that the generator had failed the self-test, indicating a gome board or switching board failure.The gome board was replaced and the unit tested successfully per the operational verification procedure.The unit meets all acceptance criteria.The customer's reported complaint description was confirmed.A review of the log files found that the generator had failed the self-test.The patient did not suffer any harm or injury due to a prolonged procedure.This was the first time the gome board has been replaced since the unit was delivered to the account in december 2011.The most likely root cause for the defective gome board is normal wear and tear.A review of the hardware service records for the complainant's ire generator (serial number (b)(4)) noted no issues.The user manual, instructs the user to reboot the system to let the auto-test check the system.Repeat any portions of ablation that were not delivered.Disposable device review: this angiodynamics hardware unit has a related disposable device however the reported complaint could not be related to the disposable device.An issue with the single use electrode probes could not cause or contribute to a gome board failing.A review of the associated disposable device's lot history records and complaint history is not required.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 SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION DEVICE
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 6046891
• MDR Text Key: 58073424
• Report Number: 1319211-2016-00144
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: No
• 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: 10/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2016
• 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