MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-15 for ENDOCHOICE COMPLIANCE ENDOKIT 205664 CEK72120 manufactured by Boston Scientific/endochoice.
[100439274]
Brush head broke off and was lodged in endoscope, this is the second (formerly reported to management and documented) occurrence with this product, but it had happened several times previous, but was discovered and removed from the scope before going into hdl processor. We do not have the specific pieces available, they were put into the trash.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075302 |
| MDR Report Key | 7276130 |
| Date Received | 2018-02-15 |
| Date of Report | 2018-02-14 |
| Date of Event | 2018-02-02 |
| 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 COMPLIANCE ENDOKIT |
| Generic Name | TRAY, BIOPSY, WITHOUT BIOPSY INSTRUMENTS |
| Product Code | FCH |
| Date Received | 2018-02-15 |
| Model Number | 205664 |
| Catalog Number | CEK72120 |
| Lot Number | 2056646 |
| Device Expiration Date | 2019-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| 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 |