MAUDE manufacturer profile
OLYMPUS WINTER & IBE GMBH · HBI
MAUDE profile for Illuminator, Fiberoptic, Surgical Field
Key facts
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
|---|---|
| Manufacturer group | OLYMPUS WINTER & IBE GMBH |
| Product code | HBI |
| Product code name | Illuminator, Fiberoptic, Surgical Field |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Burn(s), Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Burn, Thermal, Fire, Unclear Information, Overheating of Device, Thermal Decomposition 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