MAUDE manufacturer profile
OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT · FED
MAUDE profile for Endoscopic Access Overtube, Gastroenterology-Urology
Key facts
| Manufacturer | OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT |
|---|---|
| Manufacturer group | OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT |
| Product code | FED |
| Product code name | Endoscopic Access Overtube, Gastroenterology-Urology |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Bowel Perforation, Inflation Problem, High White Blood Cell Count, Cholangitis, Chills, Fever, Perforation 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