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.
[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
Report Number | 6000030-2020-00026 |
MDR Report Key | 9720118 |
Report Source | COMPANY REPRESENTATIVE |
Date Received | 2020-02-18 |
Date of Report | 2020-04-02 |
Date Mfgr Received | 2020-03-31 |
Device Manufacturer Date | 2019-09-05 |
Date Added to Maude | 2020-02-18 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | LISA WOODWARD CLARK |
Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
Manufacturer City | MINNEAPOLIS MN 55432 |
Manufacturer Country | US |
Manufacturer Postal | 55432 |
Manufacturer Phone | 7635263920 |
Manufacturer G1 | RICE CREEK MFG |
Manufacturer Street | 7000 CENTRAL AVE NE |
Manufacturer City | FRIDLEY MN 55432 |
Manufacturer Country | US |
Manufacturer Postal Code | 55432 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ACCURIAN |
Generic Name | GENERATOR, LESION, RADIOFREQUENCY |
Product Code | GXD |
Date Received | 2020-02-18 |
Model Number | AG1000 |
Catalog Number | AG1000 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | RICE CREEK MFG |
Manufacturer Address | 7000 CENTRAL AVE NE FRIDLEY MN 55432 US 55432 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-02-18 |