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

Model Number 20300101

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2013

Event Type  malfunction  

Event Description

As reported on (b)(6) 2013, patient of unknown gender and age presented for a lecd thermal ablation.During the procedure, it was reported the nanoknife unit experienced a hardware communication error message, shutting the unit down.The unit down was rebooted, and the procedure was successfully completed using the same unit.However, due to the delay during the procedure, the patient was administered additional medication.It was reported the patient suffered no harm or injury 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 device involved in the incident is available to be returned to the manufacturer for evaluation.To date the device has yet to 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.(b)(4).

• Brand Name: NANOKNIFE SYSTEM
• 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: 3647992
• MDR Text Key: 4183527
• Report Number: 1319211-2014-00002
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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