MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-28 for CAUDAL ELEVATOR N4660 * manufactured by Karl Storz.
[1710634]
During the beginning of the approach for the transsphenodal surgery, the doctor noted that a caudal elevator broke apart inside the nose. This resulted in a piece of the elevator remaining inside the nose. The piece was retrieved by the surgeon within a few minutes. The pieces appear to fit together without any missing parts. An x-ray was taken to check for any remaining parts. The x-ray was clear.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1993177 |
| MDR Report Key | 1993177 |
| Date Received | 2011-01-28 |
| Date of Report | 2011-01-28 |
| Date of Event | 2011-01-27 |
| Report Date | 2011-01-28 |
| Date Reported to FDA | 2011-01-28 |
| Date Added to Maude | 2011-02-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAUDAL ELEVATOR |
| Generic Name | ELEVATOR, ENT |
| Product Code | KAD |
| Date Received | 2011-01-28 |
| Model Number | N4660 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ |
| Manufacturer Address | 2151 E. GRAND AVENUE EL SEGUNDO CA 90245501 US 90245 5017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-28 |