MAUDE manufacturer profile
UNITED STATES ENDOSCOPY GROUP, INC. · GEI
MAUDE profile for Electrosurgical, Cutting & Coagulation & Accessories
Key facts
| Manufacturer | UNITED STATES ENDOSCOPY GROUP, INC. |
|---|---|
| Manufacturer group | UNITED STATES ENDOSCOPY GROUP, INC. |
| Product code | GEI |
| Product code name | Electrosurgical, Cutting & Coagulation & Accessories |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Insufficient Information, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Failure to Deliver Energy, Perforation, Use of Device Problem, Adverse Event Without Identified Device or Use Problem, No Display/Image 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