MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-10-17 for * manufactured by Medtronic, Inc..
[357574]
A pt was undergoing a repeat right radical mastoidectomy with meatoplasty for removal of a right ear cholesteatoma. While a portion of the cholesteatoma was being removed with the round knife in the area of the sinus tympani, a very small piece of the tip of the round knife broke off. The area wa insepected and the piece could not be visualized. Because of the location of the dissection (area of the facial nerve) the surgeon decided to leave the piece in situ.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 505788 |
| MDR Report Key | 505788 |
| Date Received | 2003-10-17 |
| Date of Event | 2003-09-01 |
| Date Added to Maude | 2004-01-13 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | ROUND KNIFE |
| Product Code | EMF |
| Date Received | 2003-10-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Age | 3 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 494655 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 7000 CENTRAL AVE, NE MAIL STOP: CW 304 (CRM WEST) MINNEAPOLIS MN 55432 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-10-17 |