MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-30 for KARL STORZ CYSTOSCOPE SHEATH 20 FRENCH CYSTOURETHROSCOPE 27028-CA manufactured by Karl Storz.
[71678218]
Back end of the 20 french cystoscope fractured off in the patient's bladder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068847 |
| MDR Report Key | 6453137 |
| Date Received | 2017-03-30 |
| Date of Report | 2017-03-15 |
| Date of Event | 2017-09-03 |
| Date Added to Maude | 2017-04-03 |
| 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 CAREGIVERS |
| 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 | KARL STORZ CYSTOSCOPE SHEATH 20 FRENCH CYSTOURETHROSCOPE |
| Generic Name | CYSTOSCOPE |
| Product Code | FBO |
| Date Received | 2017-03-30 |
| Model Number | 27028-CA |
| Lot Number | UW03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ |
| Manufacturer Address | 2151 E GRAND AVE EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-03-30 |