MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-03 for CYSTO-URETHRO-FIBERSCOPE 11272C1 manufactured by Karl Storz Endovision.
| Report Number | 1221826-2019-00088 |
| MDR Report Key | 9152668 |
| Date Received | 2019-10-03 |
| Date of Report | 2019-09-04 |
| Date of Event | 2019-01-15 |
| Date Mfgr Received | 2019-09-04 |
| Device Manufacturer Date | 2012-04-23 |
| Date Added to Maude | 2019-10-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 EAST GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer G1 | KARL STORZ ENDOVISION |
| Manufacturer Street | 91 CARPENTER HILL ROAD |
| Manufacturer City | CHARLTON MA 01507 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01507 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CYSTO-URETHRO-FIBERSCOPE |
| Generic Name | FLEXIBLE URETHROSCOPE |
| Product Code | FBO |
| Date Received | 2019-10-03 |
| Model Number | 11272C1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOVISION |
| Manufacturer Address | 91 CARPENTER HILL ROAD CHARLTON MA 01507 US 01507 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-03 |