MAUDE manufacturer profile
KARL STORZ ENDOSCOPY-AMERICA, INC. · FJL
MAUDE profile for Resectoscope
Key facts
| Manufacturer | KARL STORZ ENDOSCOPY-AMERICA, INC. |
|---|---|
| Manufacturer group | KARL STORZ SE & CO. KG |
| Product code | FJL |
| Product code name | Resectoscope |
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 Known Impact Or Consequence To Patient, Material Fragmentation, Detachment of Device or Device Component, Foreign Body In Patient, Insufficient Information, No Clinical Signs, Symptoms or Conditions, 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