MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-21 for DUR-8ULTRA URETEROSCOPE manufactured by Gyrus Acmi, Inc.
| Report Number | 2951238-2020-00345 |
| MDR Report Key | 9738659 |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2015-06-10 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-02-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUR-8ULTRA URETEROSCOPE |
| Generic Name | URETEROSCOPE |
| Product Code | FGB |
| Date Received | 2020-02-21 |
| Returned To Mfg | 2019-12-11 |
| Model Number | DUR-8ULTRA |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |