MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-18 for VIZISHOT SINGLE USE INSPIRATION NEEDLE NA-201SX-4021 manufactured by Olympus Medical Systems, Corp..
| Report Number | MW5090475 |
| MDR Report Key | 9213627 |
| Date Received | 2019-10-18 |
| Date of Report | 2019-10-17 |
| Date of Event | 2019-10-07 |
| Date Added to Maude | 2019-10-21 |
| 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 | RISK MANAGER |
| 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 | 3 |
| Brand Name | VIZISHOT SINGLE USE INSPIRATION NEEDLE |
| Generic Name | BRONCHOSCOPE ACCESSORY |
| Product Code | KTI |
| Date Received | 2019-10-18 |
| Catalog Number | NA-201SX-4021 |
| Lot Number | 91V |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS MEDICAL SYSTEMS, CORP. |
| Manufacturer Address | ISHIKAWA-CHO HACHIOJI-SHI 192-8507 JA 192-8507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-18 |