MAUDE manufacturer profile
OLYMPUS · FDT
MAUDE profile for Duodenoscope And Accessories, Flexible/Rigid
Key facts
| Manufacturer | OLYMPUS |
|---|---|
| Manufacturer group | AIZU OLYMPUS CO., LTD. |
| Product code | FDT |
| Product code name | Duodenoscope And Accessories, Flexible/Rigid |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Bacterial Infection, Insufficient Information, Microbial Contamination of Device, Death, Design/structure problem, No Known Impact Or Consequence To Patient, Device Reprocessing Problem, Contamination 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