ACCURIAN AG1000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-18 for ACCURIAN AG1000 manufactured by Rice Creek Mfg.

Event Text Entries

[186751135] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[186751136] Information was received from a manufacturer representative regarding a radiofrequency ablation (rfa) system. It was reported that there was a f07 code displayed on the generator. It was reported that the system was sent in for analysis. It was reported that the rma #s for the generator and hub are 2070035 and 2070036 respectively. Additional information was received from a manufacturer representative (rep). It was reported that the f07 error occurred during a live procedure upon pressing the energy delivery button in motor mode. The system showed the f07 error immediately, and no energy was delivered. A second rfa system was used with the same results. The patient was treated with a competitor's system that they had on hand. It was reported that the generator was sent straight to rbc for analysis. The following tracking numbers were provided: (b)(4). No symptoms or complications were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6000030-2020-00026
MDR Report Key9720118
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-02-18
Date of Report2020-04-02
Date Mfgr Received2020-03-31
Device Manufacturer Date2019-09-05
Date Added to Maude2020-02-18
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 ContactLISA WOODWARD CLARK
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635263920
Manufacturer G1RICE CREEK MFG
Manufacturer Street7000 CENTRAL AVE NE
Manufacturer CityFRIDLEY MN 55432
Manufacturer CountryUS
Manufacturer Postal Code55432
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACCURIAN
Generic NameGENERATOR, LESION, RADIOFREQUENCY
Product CodeGXD
Date Received2020-02-18
Model NumberAG1000
Catalog NumberAG1000
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerRICE CREEK MFG
Manufacturer Address7000 CENTRAL AVE NE FRIDLEY MN 55432 US 55432


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-18

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