MAUDE manufacturer profile
OLYMPUS MEDICAL SYSTEM CORP · FDT
MAUDE profile for Duodenoscope And Accessories, Flexible/Rigid
Key facts
| Manufacturer | OLYMPUS MEDICAL SYSTEM CORP |
|---|---|
| Manufacturer group | OLYMPUS MEDICAL SYSTEM CORP |
| Product code | FDT |
| Product code name | Duodenoscope And Accessories, Flexible/Rigid |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Bacterial Infection, Microbial Contamination of Device, Adverse Event Without Identified Device or Use Problem, Death, Unspecified Infection, Contamination, Device Reprocessing Problem, No Patient Involvement Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1