MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-29 for VIZISHOT 2 FLEX NA-U403SX-4019 manufactured by Olympus / Gyrus Acmi, Inc..
[140540933]
During pt procedure, the utilized ebus aspiration needle malfunctioned. It is unk when or how, but what appeared to be a soft, flexible metal spring piece was found in pt's bronchus. The piece was safely retrieved with forceps and no harm reached the pt at that time. The pt was inpatient and already being closely monitored. Planned return of pieces to the mfr for review on march 29, 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085418 |
| MDR Report Key | 8470557 |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-28 |
| Date of Event | 2019-03-27 |
| Date Added to Maude | 2019-04-01 |
| 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 |
| 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 2 FLEX |
| Generic Name | BRONCHOSCOPE ACCESSORY |
| Product Code | KTI |
| Date Received | 2019-03-29 |
| Model Number | NA-U403SX-4019 |
| Lot Number | FR837912 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS / GYRUS ACMI, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-29 |