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 |