MAUDE manufacturer profile
OLYMPUS · FDF
MAUDE profile for Colonoscope And Accessories, Flexible/Rigid
Key facts
| Manufacturer | OLYMPUS |
|---|---|
| Manufacturer group | AIZU OLYMPUS CO., LTD. |
| Product code | FDF |
| Product code name | Colonoscope And Accessories, Flexible/Rigid |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Device Operates Differently Than Expected, Failure to Clean Adequately, Leak/Splash, No Information, Fluid/Blood Leak, Insufficient Information 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