MAUDE manufacturer profile
GYRUS ACMI, INC. · KTI
MAUDE profile for Bronchoscope Accessory
Key facts
| Manufacturer | GYRUS ACMI, INC. |
|---|---|
| Manufacturer group | GYRUS ACMI, INC. |
| Product code | KTI |
| Product code name | Bronchoscope Accessory |
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, Break, Detachment of Device or Device Component, Mechanical Problem, Retraction Problem, No Consequences Or Impact To Patient, Foreign Body In Patient, Physical Resistance/Sticking 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