NANOKNIFE SYSTEM 20300101

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-03-25 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.

Event Text Entries

[4411700] As reported on (b)(6) 2014, patient of unknown gender and age presented for a lecd thermal ablation of the kidney. While prepping for the procedure, it was reported the nanoknife unit failed its self-test. The procedure was not completed due to this event. Due to the delay during the procedure, the patient was anesthetized for greater than 30 minutes. 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.
Patient Sequence No: 1, Text Type: D, B5


[12112590] 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).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1319211-2014-00027
MDR Report Key3851225
Report Source06
Date Received2014-03-25
Date of Report2014-02-27
Date of Event2014-02-27
Date Mfgr Received2014-02-27
Date Added to Maude2014-06-19
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 FDA0
Event Location0
Manufacturer ContactDAN ANDERSON
Manufacturer Street603 QUEENSBURY AVE.
Manufacturer CityQUEENSBURY NY 12804
Manufacturer CountryUS
Manufacturer Postal12804
Manufacturer Phone5187981215
Manufacturer G1ANGIODYNAMICS
Manufacturer Street603 QUEENSBURY AVE.
Manufacturer CityQUEENSBURY NY 12804
Manufacturer CountryUS
Manufacturer Postal Code12804
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNANOKNIFE SYSTEM
Generic NameLECD THERMAL ABLATION SYSTEM
Product CodeOAB
Date Received2014-03-25
Model Number20300101
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerANGIODYNAMICS
Manufacturer AddressQUEENSBURY NY US


Patients

Patient NumberTreatmentOutcomeDate
10 2014-03-25

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