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U.S. Department of Health and Human Services

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

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ANGIODYNAMICS NANOKNIFE SYSTEM LOW ENERGY DIRECT CURRENT ABLATION DEVICE Back to Search Results
Model Number 20300101
Device Problems Device Stops Intermittently (1599); Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 03/21/2016
Event Type  malfunction  
Manufacturer Narrative
It was reported that the user has declined to return the nanoknife system (sn (b)(4)) involved in the incident to the manufacturer for assessment and repair at this time. Attempts are being made by angiodynamics to obtain additional information in regards to the event. An investigation into the root cause for the event is currently in process. A review of the service history 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. Complaint # (b)(4). Device is not available for return.
 
Event Description
As reported (b)(6) 2016, a patient of unknown age and gender presented for an ire (irreversible electroporation) procedure. It was reported that during the procedure, the nanoknife system shut down multiple times. The unit was restarted and the procedure was resumed each time. There was no report of harm or injury to the patient due to the event. As there was a delay in the procedure, the patient was assumed to be under anesthesia for an extended period of time. It was reported the customer declined to return the nanoknife system for assessment and repair at this time.
 
Manufacturer Narrative
The nanoknife generator (sn (b)(4)) was returned for evaluation and repair. The unit returned with a damaged front wheel. No additional damage was noted. The unit was tested per the operational verification procedure and at additional settings to determine if reported error could be duplicated. The reported error could not be duplicated, however, the error log had a recorded failure of the fpga board during the previous use that would suggest the unit had shut down during use. Although the reported fault could not be duplicated during functional testing, the complaint is confirmed based on a review of the unit's error logs. Based on the error logs, the root cause for the unit shutting down was a failure of the fpga board. This was the first repair since the unit was delivered to the account in (b)(6) 2014. The most likely root cause for the fpga board is wear and tear. The fpga board was replaced, and the damaged wheel was realigned. The user manual (nanoknife user manual, 160-105261 rev 01 version 2. 2. 1), instructs the user to reboot the system to let the auto-test check the system. Repeat any portions of ablation that were not delivered. 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. (b)(4).
 
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Brand NameNANOKNIFE SYSTEM
Type of DeviceLOW 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 Key5573404
MDR Text Key42525521
Report Number1319211-2016-00056
Device Sequence Number1
Product Code OAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102329
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20300101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2016
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

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