MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-20 for STORZ N4660 manufactured by Storz.
[16737779]
A (b)(6) male with chronic sinusitis underwent an ethmoidectomy and a small piece of a storz caudal elevator broke off inside the patient's nose during the surgery. The m. D. Was able to retrieve the piece and no permanent harm to patient. Discharged from hospital same day surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5023977 |
| MDR Report Key | 2430087 |
| Date Received | 2012-01-20 |
| Date of Report | 2012-01-20 |
| Date of Event | 2012-01-03 |
| Date Added to Maude | 2012-01-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ |
| Generic Name | CAUDAL ELEVATOR |
| Product Code | KAD |
| Date Received | 2012-01-20 |
| Model Number | N4660 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STORZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-01-20 |