MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-30 for MONTERIS MEDICAL NBP-001-01 manufactured by Monteris Medical.
[53600756]
During neuroblate procedure, tip of probe was detached from base.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064408 |
| MDR Report Key | 5913323 |
| Date Received | 2016-08-30 |
| Date of Report | 2016-07-26 |
| Date of Event | 2016-07-25 |
| Date Added to Maude | 2016-08-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MONTERIS MEDICAL |
| Generic Name | SIDEFIRE DIRECTIONAL LASER PROBE |
| Product Code | HQB |
| Date Received | 2016-08-30 |
| Model Number | NBP-001-01 |
| Device Expiration Date | 2017-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MONTERIS MEDICAL |
| Manufacturer Address | 16305 360 AVENUE STE 200 PLYMOUTH MN 55466 US 55466 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-08-30 |