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.
[180519778]
Concomitant device: reusable electrode, 10cm, nitinol. The device functioned as intended during a simulated lesion test. No visual or functional anomalies were noted. The device was manufactured according to specifications as supported by the receiving inspection results. The cause of the reported smoking remains unknown.
Patient Sequence No: 1, Text Type: N, H10
[180519779]
Related manufacturing ref: 3004617090-2020-00002. 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 | 3004617090-2020-00003 |
| MDR Report Key | 9744198 |
| 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 | 2018-09-11 |
| 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 | 6517565400 |
| 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 | M14597 |
| 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 |