MAUDE manufacturer profile
AIZU OLYMPUS CO., LTD. · FDA
MAUDE profile for Enteroscope And Accessories
Key facts
| Manufacturer | AIZU OLYMPUS CO., LTD. |
|---|---|
| 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
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Failure to Clean Adequately, Adverse Event Without Identified Device or Use Problem, Microbial Contamination of Device, Device Reprocessing Problem, Pancreatitis, Perforation, Bowel 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