NANOKNIFE SYSTEM 20300101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-06-12 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics, Inc.

MAUDE Entry Details

Report Number1319211-2019-00052
MDR Report Key8692373
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-06-12
Date of Report2019-06-05
Date of Event2019-05-13
Date Mfgr Received2019-05-13
Date Added to Maude2019-06-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLAW RYAN
Manufacturer Street10 GLENS FALLS TECHNICAL PARK
Manufacturer CityGLENS FALLS NY 12801
Manufacturer CountryUS
Manufacturer Postal12801
Manufacturer Phone5187424488
Manufacturer G1ANGIODYNAMICS
Manufacturer Street10 GLENS FALLS TECHNICAL PARK
Manufacturer CityGLENS FALLS NY 12801
Manufacturer CountryUS
Manufacturer Postal Code12801
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNANOKNIFE SYSTEM
Generic NameLOW ENERGY DIRECT CURRENT ABLATION SYSTEM,
Product CodeOAB
Date Received2019-06-12
Returned To Mfg2019-05-13
Model Number20300101
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerANGIODYNAMICS, INC
Manufacturer Address603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-06-12

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