MAUDE manufacturer profile
OLYMPUS · FDS
MAUDE profile for Gastroscope And Accessories, Flexible/Rigid
Key facts
| Manufacturer | OLYMPUS |
|---|---|
| Manufacturer group | AIZU OLYMPUS CO., LTD. |
| Product code | FDS |
| Product code name | Gastroscope And Accessories, Flexible/Rigid |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Device Reprocessing Problem, Bacterial Infection, Device Disinfection Or Sterilization Issue, Failure to Clean Adequately, Protective Measures Problem, Manufacturing, Packaging or Shipping Problem, Device Contamination with Chemical or Other Material 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