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

Model Number 20300101

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 07/27/2014

Event Type  Injury  

Event Description

A male pt of unknown age presented for a lecd thermal ablation of the prostate on (b)(6)2014.The procedure was successfully completed with no reports of patient complications or device malfunctions.Within a few days post procedure, the pt reported marks to his lower legs (knees) and blistering appeared approx.Two weeks post procedure.By the time the pt made the treating physician that the probe and device cables were not placed near the lower legs during the procedure.The device cables did not exhibit any damage to the cable insulation.There is no report of permanent harm or injury to the patient due to this event.No further intervention has been taken to address the blistering.The symptoms have been self-limiting and are resolving.The disposable device used for the procedure is not available for return to the manufacturer for evaluation as it was disposed of by the end user.The nanoknife generator has been retained by the user as it functioned as intended and there is no report of malfunction.

Manufacturer Narrative

The reported nanoknife unit (sn (b)(4)) has been retained by the account and will not be returned to the manufacturer for evaluation, as there is no report of malfunction, but a report of a patient issue.An investigation into the root cause of this incident is currently in progress.The results of the investigation and any follow up information will be sent via a follow up medwatch.A review of the device history records was performed for the reported serial number (b)(4) for any deviations related to the reported defect of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution.No complications were noted during the operation in either the medical notes or the operation note.The probes are placed in the perineum, the legs are in stirrups with the patient in the lithotomy position.The probe cables came down underneath the patient's legs and away.They are not placed over the top or across the legs of the patients.They did not come into contact with the patient.No further investigation has been taken to address the blistering.The symptoms have been self-limiting and are resolving.Complaint # (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: 4173241
• MDR Text Key: 5099497
• Report Number: 1319211-2014-00124
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K0800376
• 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: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20300101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2014
• 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
• Patient Outcome(s): Required Intervention