MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-09 for MEDLINE ENDOSCOPE CLEANING BRUSH REF # DYK1002DBDE manufactured by Medline.
[108093963]
Endoscope cleaning brush head broke inside endoscope and remained lodged in scope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077099 |
| MDR Report Key | 7502155 |
| Date Received | 2018-05-09 |
| Date of Report | 2018-05-07 |
| Date of Event | 2018-05-01 |
| Date Added to Maude | 2018-05-10 |
| 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 | MEDLINE ENDOSCOPE CLEANING BRUSH |
| Generic Name | BRUSH, SCRUB, OPERATING ROOM |
| Product Code | GEC |
| Date Received | 2018-05-09 |
| Model Number | REF # DYK1002DBDE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-09 |