MAUDE manufacturer profile
OLYMPUS WINTER & IBE GMBH · FJL
MAUDE profile for Resectoscope
Key facts
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
|---|---|
| Manufacturer group | OLYMPUS WINTER & IBE GMBH |
| Product code | FJL |
| Product code name | Resectoscope |
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
- Break, Fracture, Material Fragmentation, Mechanical Problem, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Foreign Body In Patient, Detachment of Device or Device Component 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