MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-24 for REUSABLE ELECTRODE, 10CM, NITINOL RF-NE-10 manufactured by Minta Medical Limited.
[180519827]
Concomitant device: reusable electrode, 10cm, nitinol. The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.?
Patient Sequence No: 1, Text Type: N, H10
[180519828]
Related manufacturing ref: 3004617090-2020-00003. During device testing, the probes started smoking when testing on the grounding pad. There was no patient involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004617090-2020-00002 |
| MDR Report Key | 9744181 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2019-07-18 |
| Date Added to Maude | 2020-02-24 |
| 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 | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 1111651756 |
| Manufacturer G1 | MINTA MEDICAL LIMITED |
| Manufacturer Street | CADDICK ROAD |
| Manufacturer City | MERSEYSIDE KNOWSLEY L34 9HP |
| Manufacturer Country | UK |
| Manufacturer Postal Code | L34 9HP |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REUSABLE ELECTRODE, 10CM, NITINOL |
| Generic Name | PROBE, RADIOFREQUENCY LESION |
| Product Code | GXI |
| Date Received | 2020-02-24 |
| Returned To Mfg | 2020-02-05 |
| Model Number | RF-NE-10 |
| Catalog Number | RF-NE-10 |
| Lot Number | M15455 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MINTA MEDICAL LIMITED |
| Manufacturer Address | CADDICK ROAD MERSEYSIDE KNOWSLEY L34 9HP UK L34 9HP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-24 |