MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-16 for DOUBLE HEADER ENDOSCOPE BRUSH 00711609 manufactured by United States Endoscopy Group, Inc. / Steris Corp..
[133716081]
At the end of the procedure, the suction button became fixed in the depressed position. After some manipulation, we were able to free up the button and complete the case. The suction button was removed with some difficulty. During post procedure cleaning of the scope, a brush end was found lodged in the suction port.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083189 |
| MDR Report Key | 8256873 |
| Date Received | 2019-01-16 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-12-18 |
| Date Added to Maude | 2019-01-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | DOUBLE HEADER ENDOSCOPE BRUSH |
| Generic Name | ACCESSORIES, CLEANING BRUSHES FOR ENDOSCOPE |
| Product Code | MNL |
| Date Received | 2019-01-16 |
| Catalog Number | 00711609 |
| Lot Number | 1808455 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED STATES ENDOSCOPY GROUP, INC. / STERIS CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-16 |