FDA Adverse Event
Summary report: N
BEAVER MINI-BLADE
MDR report key: 2897210
·
Received December 26, 2012
Report
- Report Number
- 2897210
- Date Received
- December 26, 2012
- Report Date
- December 26, 2012
- Manufacturer
- BEAVER VISITEC INTERNATIONAL
- Product Code
- GES
- Report Source
- User Facility report
- Reporter Location
- OR, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
NEW MODELS OF THIS MINI BLADE ARE NOW MADE WITH A WIDENED BODY WITH AN INDENT MEANT TO STABILIZE THE DEVICE IN THE SHIPPING PACKAGE. THE WIDENED BODY MAKES IT IMPOSSIBLE FOR THE SURGEON TO SEE THE BLADE ITSELF AND BEYOND TO THE TISSUE THEY INTEND TO CUT, BECAUSE THE WIDE BODY BLOCKS THE VIEW DOWN THE MICROSCOPE. ELECTRONIC FILE AVAILABLE ON REQUEST TO MEDSUN AS NEEDED TO ILLUSTRATE THE NEW DESIGN AND CONFIGURATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BEAVER MINI-BLADE | BLADE, SCALPEL | GES | BEAVER VISITEC INTERNATIONAL | BEAVER 6400 MINI-BLADE | 3015268 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |