MAUDE manufacturer profile
UNITED STATES ENDOSCOPY GROUP, INC. · PKL
MAUDE profile for Hemostatic Metal Clip For The Gi Tract
Key facts
| Manufacturer | UNITED STATES ENDOSCOPY GROUP, INC. |
|---|---|
| Manufacturer group | UNITED STATES ENDOSCOPY GROUP, INC. |
| Product code | PKL |
| Product code name | Hemostatic Metal Clip For The Gi Tract |
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, Failure to Fire, No Known Impact Or Consequence To Patient, Material Protrusion/Extrusion, Detachment of Device or Device Component, Activation, Positioning or Separation Problem, Defective Component, Failure to Eject 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