MAUDE manufacturer profile
OLYMPUS MEDICAL SYSTEMS CORP. · FDA
MAUDE profile for Enteroscope And Accessories
Key facts
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. |
|---|---|
| Manufacturer group | AIZU OLYMPUS CO., LTD. |
| Product code | FDA |
| Product code name | Enteroscope And Accessories |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Perforation, Inflammation, Appropriate Term/Code Not Available, No Code Available, Not Applicable, Insufficient Information, Microbial Contamination of Device 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