MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-05 for CELLEBRITY * M00516150 manufactured by Boston Scientific Corporation.
[16862397]
In an attempt to retrieve the brush back into the sheath, the sheath bent and it was difficult to get the brush back into the sheath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4493783 |
| MDR Report Key | 4493783 |
| Date Received | 2015-01-05 |
| Date of Report | 2015-01-05 |
| Date of Event | 2014-12-29 |
| Report Date | 2015-01-05 |
| Date Reported to FDA | 2015-01-05 |
| Date Reported to Mfgr | 2015-02-09 |
| Date Added to Maude | 2015-02-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELLEBRITY |
| Generic Name | BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) |
| Product Code | BTG |
| Date Received | 2015-01-05 |
| Model Number | * |
| Catalog Number | M00516150 |
| Lot Number | 17141465 |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 780 BROOKSIDE DRIVE SPENCER IN 47460 US 47460 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-05 |