MAUDE manufacturer profile
COOK ENDOSCOPY · PKL
MAUDE profile for Hemostatic Metal Clip For The Gi Tract
Key facts
| Manufacturer | COOK ENDOSCOPY |
|---|---|
| Manufacturer group | COOK ENDOSCOPY |
| Product code | PKL |
| Product code name | Hemostatic Metal Clip For The Gi Tract |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Separation Failure, Failure to Fire, Premature Activation, Foreign Body In Patient, Premature Separation, Difficult or Delayed Separation 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