MAUDE manufacturer profile
LINA MEDICAL APS · GEI
MAUDE profile for Electrosurgical, Cutting & Coagulation & Accessories
Key facts
| Manufacturer | LINA MEDICAL APS |
|---|---|
| Manufacturer group | STRYKER INSTRUMENTS-IRELAND |
| Product code | GEI |
| Product code name | Electrosurgical, Cutting & Coagulation & Accessories |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Delivered as Unsterile Product, No Clinical Signs, Symptoms or Conditions, No Patient Involvement, Energy Output Problem, Insufficient Information, Overheating of Device, Burn(s), Failure to Deliver Energy 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