MAUDE manufacturer profile
STRYKER INSTRUMENTS-KALAMAZOO · GEI
MAUDE profile for Electrosurgical, Cutting & Coagulation & Accessories
Key facts
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
|---|---|
| Manufacturer group | STRYKER INSTRUMENTS-IRELAND |
| Product code | GEI |
| Product code name | Electrosurgical, Cutting & Coagulation & Accessories |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Patient Involvement, Unintended Power Up, Detachment of Device or Device Component, No Consequences Or Impact To Patient, Delivered as Unsterile Product, Fracture, Device Remains Activated 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