MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-02 for CHANDELIER FIBER PROBE WITH ADJUSTIABLE RING, 25G 5316 manufactured by Microvision, Inc..
| Report Number | 1226011-2019-00001 |
| MDR Report Key | 9147283 |
| Date Received | 2019-10-02 |
| Date Added to Maude | 2019-10-02 |
| 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 | MR MATTHEW CARIGNAN |
| Manufacturer Street | 20 LONDON LANE |
| Manufacturer City | SEABROOK NH 03874 |
| Manufacturer Country | US |
| Manufacturer Postal | 03874 |
| Manufacturer G1 | MICROVISION, INC. |
| Manufacturer Street | 20 LONDON LANE |
| Manufacturer City | SEABROOK NH 03874 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03874 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CHANDELIER FIBER PROBE WITH ADJUSTIABLE RING, 25G |
| Generic Name | FIBER OPTIC ENDOILLUMINATION PROBE |
| Product Code | FFS |
| Date Received | 2019-10-02 |
| Catalog Number | 5316 |
| Lot Number | 1807120 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROVISION, INC. |
| Manufacturer Address | 20 LONDON LANE SEABROOK NH 03874 US 03874 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-02 |