MAUDE manufacturer profile
ETHICON ENDO-SURGERY, LLC. · GDW
MAUDE profile for Staple, Implantable
Key facts
| Manufacturer | ETHICON ENDO-SURGERY, LLC. |
|---|---|
| Manufacturer group | ETHICON ENDO-SURGERY, LLC. |
| Product code | GDW |
| Product code name | Staple, Implantable |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Failure to Fire, Failure to Form Staple, Difficult to Open or Close, Adverse Event Without Identified Device or Use Problem, No Code Available, Failure to Anastomose 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