MAUDE manufacturer profile
ETHICON ENDO-SURGERY, LLC. · OCW
MAUDE profile for Endoscopic Tissue Approximation Device
Key facts
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
|---|---|
| Manufacturer group | ETHICON ENDO-SURGERY, LLC. |
| Product code | OCW |
| Product code name | Endoscopic Tissue Approximation Device |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Failure to Form Staple, No Consequences Or Impact To Patient, Device Operates Differently Than Expected, Failure to Fire, Insufficient Information, Nonstandard Device, Leak/Splash 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