MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-02 for SHEATH - INNER W/CERAMIC INSULATE R27040X4 manufactured by Karl Storz Endoscopy - America Inc..
| Report Number | MW5090188 |
| MDR Report Key | 9150906 |
| Date Received | 2019-10-02 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-07-12 |
| Date Added to Maude | 2019-10-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | UNKNOWN |
| 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 | SHEATH - INNER W/CERAMIC INSULATE |
| Generic Name | RESECTOSCOPE - URETER |
| Product Code | FJL |
| Date Received | 2019-10-02 |
| Model Number | R27040X4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY - AMERICA INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-02 |