MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE M00564100 manufactured by Boston Scientific Corp..
[181528659]
The boston scientific excelon transbronchial aspiration needle was inserted into the biopsy port on the bronchoscope. Scrub tech unable to apply suction to syringe to aspirated fluid. There was a small bend noted at the distal end of the device. Troubleshooting was performed, and suction was still not working on the syringe. Opened another aspiration needle and had no issues with it. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093291 |
| MDR Report Key | 9753976 |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-02-21 |
| Date Added to Maude | 2020-02-26 |
| 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 | EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE |
| Generic Name | BRONCHOSCOPE (FLEXIBLE OR RIGID) |
| Product Code | EOQ |
| Date Received | 2020-02-25 |
| Catalog Number | M00564100 |
| Lot Number | 22985552 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-25 |