MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-29 for US ENDOSCOPY INFINITY ERCP SAMPLING BRUSH 00711653 manufactured by Us Endoscopy Group, Inc..
[140540654]
Radiopaque marker dislodged in common bile duct. Additional procedure needed to remove and treat.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085400 |
| MDR Report Key | 8470353 |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-03-12 |
| 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 | US ENDOSCOPY INFINITY ERCP SAMPLING BRUSH |
| Generic Name | CYTOLOGY BRUSH |
| Product Code | FDX |
| Date Received | 2019-03-29 |
| Model Number | 00711653 |
| Catalog Number | 00711653 |
| Lot Number | 1809100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | US ENDOSCOPY GROUP, INC. |
| Manufacturer Address | MENTOR OR 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-03-29 |