MAUDE manufacturer profile
GYRUS ACMI, INC. · FBO
MAUDE profile for Cystourethroscope
Key facts
| Manufacturer | GYRUS ACMI, INC. |
|---|---|
| Manufacturer group | GYRUS ACMI, INC. |
| Product code | FBO |
| Product code name | Cystourethroscope |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Sparking, No Known Impact Or Consequence To Patient, Break, Smoking, Flare or Flash, Crack, No Patient Involvement 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