MAUDE Adverse Event Report: ANGIODYNAMICS NANOKNIFE SINGLE ELECTRODE PROBE, 15CM; LECD THERMAL ABLATION SYSTEM

Catalog Number 20400101

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2014

Event Type  malfunction  

Event Description

As reported (b)(6) 2014, a pt of unk age and gender presented for a nanoknife ablation procedure of the pancreas.During the procedure the treating physician noted high voltage registering between two probes.The voltage was adjusted down, and the treatment was initiated.The unit then displayed a high voltage and a mandatory stop message displayed.The treating physician shut down the unit, and exchanged the probes with a new of the same.Treatment was restarted, and the event reoccurred.The procedure was stopped at that time.There was no report of harm or injury to the pt due to this event.It was reported that the disposable device is available for return to the manufacturer for eval.

Manufacturer Narrative

The reported defective device has yet to be returned to the manufacturer for a device eval.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device eval will be sent via a follow up medwatch.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.(b)(4).

• Brand Name: NANOKNIFE SINGLE ELECTRODE PROBE, 15CM
• Type of Device: LECD THERMAL ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS; queensbury NY
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury ave.; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave.; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 3804612
• MDR Text Key: 4365658
• Report Number: 1319211-2014-00021
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 20400101
• Device Lot Number: 131112
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1