MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-15 for ENDOCHOICE 205644 0100840253113337 manufactured by Boston Scientific/ Endochoice.
[100440361]
Endochoise compliance endokit hedgehog dual end brush ref cek-721-20 lot 205644 exp 08/2019. Brush end broke off and remained lodged in endoscope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075303 |
| MDR Report Key | 7276141 |
| Date Received | 2018-02-15 |
| Date of Report | 2018-02-14 |
| Date of Event | 2018-01-16 |
| Date Added to Maude | 2018-02-16 |
| 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 | 0 |
| Brand Name | ENDOCHOICE |
| Generic Name | TRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS |
| Product Code | FCH |
| Date Received | 2018-02-15 |
| Model Number | 205644 |
| Catalog Number | 0100840253113337 |
| Lot Number | 205644 |
| Device Expiration Date | 2019-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC/ ENDOCHOICE |
| Manufacturer Address | ALPHARETTA GA 30009 US 30009 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-02-15 |