MAUDE manufacturer profile
OLYMPUS WINTER & IBE GMBH · FAJ
MAUDE profile for Cystoscope And Accessories, Flexible/Rigid
Key facts
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
|---|---|
| Manufacturer group | OLYMPUS WINTER & IBE GMBH |
| Product code | FAJ |
| Product code name | Cystoscope And Accessories, Flexible/Rigid |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Detachment of Device or Device Component, Failure to Clean Adequately, Device Reprocessing Problem, Poor Quality Image, Peeled/Delaminated, Material Split, Cut or Torn, Break 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