MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-12 for VIZISHOT ASPIRATION NEEDLE NA-2015X-4022 manufactured by Olympus Surgical Technologies America.
[105561883]
Device in pt obtaining sample, unable to remove stylet. Delayed sample procurement. Endotherapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076460 |
| MDR Report Key | 7428410 |
| Date Received | 2018-04-12 |
| Date of Report | 2018-04-05 |
| Date of Event | 2018-03-22 |
| Date Added to Maude | 2018-04-13 |
| 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 | 0 |
| Brand Name | VIZISHOT ASPIRATION NEEDLE |
| Generic Name | VIZISHOT ASPIRATION NEEDLE |
| Product Code | KTI |
| Date Received | 2018-04-12 |
| Catalog Number | NA-2015X-4022 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS SURGICAL TECHNOLOGIES AMERICA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-12 |