MAUDE manufacturer profile
COOK ENDOSCOPY · GCA
MAUDE profile for Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Key facts
| Manufacturer | COOK ENDOSCOPY |
|---|---|
| Manufacturer group | COOK ENDOSCOPY |
| Product code | GCA |
| Product code name | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Foreign Body In Patient, Material Protrusion/Extrusion, Deflation Problem, Material Rupture, Burst Container or Vessel, Material Fragmentation, No Patient Involvement 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