MAUDE manufacturer profile
APOLLO ENDOSURGERY · OCW
MAUDE profile for Endoscopic Tissue Approximation Device
Key facts
| Manufacturer | APOLLO ENDOSURGERY |
|---|---|
| Manufacturer group | VIANT MEDICAL INC |
| Product code | OCW |
| Product code name | Endoscopic Tissue Approximation Device |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Break, Device-Device Incompatibility, Hemorrhage/Blood Loss/Bleeding, Insufficient Information, Difficult to Remove, Entrapment 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