MAUDE manufacturer profile
OLYMPUS WINTER & IBE GMBH · FDC
MAUDE profile for Resectoscope, Working Element
Key facts
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
|---|---|
| Manufacturer group | OLYMPUS WINTER & IBE GMBH |
| Product code | FDC |
| Product code name | Resectoscope, Working Element |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Break, No Clinical Signs, Symptoms or Conditions, Mechanical Problem, Loose or Intermittent Connection, Output Problem, Material Fragmentation, Fracture, Sparking 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