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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 Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 05/26/2016
Event Type  Injury  
Manufacturer Narrative
It was reported that the ire generator (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. 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).
 
Event Description
As reported may 31, 2016, a (b)(6), male patient presented for an ire (irreversible electroporation) procedure of the liver. During the procedure, the accusync displayed a saturation signal. This is a signal the patient experienced an episode of ventricular extrasystoles the 3 cables were replaced and the procedure was successfully completed. 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.
 
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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
dan anderson
603 queensbury avenue
queensbury, NY 12804
5187981215
MDR Report Key5706119
MDR Text Key46792091
Report Number1319211-2016-00093
Device Sequence Number1
Product Code OAB
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 05/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number20300101
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2016
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 Treatment Data
Date Received: 06/08/2016 Patient Sequence Number: 1
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