MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-03 for N.A. 27050BE manufactured by Karl Storz Gmbh Co. Kg.
[140737769]
The patient underwent cystourethroscopy with fulguration about 4 months ago. During the visual inspection, the outer sheath of the 22 fr obturator was discovered to be fractured, leaving the tip in the proximal urethra. A new scope was obtained and the fragment was removed without further complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8477516 |
| MDR Report Key | 8477516 |
| Date Received | 2019-04-03 |
| Date of Report | 2019-02-13 |
| Date of Event | 2019-01-04 |
| Report Date | 2019-02-14 |
| Date Reported to FDA | 2019-02-14 |
| Date Reported to Mfgr | 2019-04-03 |
| Date Added to Maude | 2019-04-03 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| 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 | 3 |
| Brand Name | N.A. |
| Generic Name | ENDOSCOPIC CONTAMINATION PREVENTION SHEATH |
| Product Code | ODB |
| Date Received | 2019-04-03 |
| Model Number | 27050BE |
| Device Availability | Y |
| Device Age | 14 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH CO. KG |
| Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US 90245 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-03 |