MAUDE manufacturer profile
KARL STORZ ENDOSCOPY-AMERICA. INC · FAJ
MAUDE profile for Cystoscope And Accessories, Flexible/Rigid
Key facts
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA. INC |
|---|---|
| Manufacturer group | KARL STORZ SE & CO. KG |
| Product code | FAJ |
| Product code name | Cystoscope And Accessories, Flexible/Rigid |
At a glance
- 10–99 MAUDE reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Insufficient Information, Optical Problem, No Clinical Signs, Symptoms or Conditions, Detachment of Device or Device Component, Device Reprocessing Problem, Poor Visibility, Material Deformation, Failure to Clean Adequately 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