MAUDE manufacturer profile
GYRUS ACMI, INC. · HIH
MAUDE profile for Hysteroscope (And Accessories)
Key facts
| Manufacturer | GYRUS ACMI, INC. |
|---|---|
| Manufacturer group | GYRUS ACMI, INC. |
| Product code | HIH |
| Product code name | Hysteroscope (And Accessories) |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Break, No Clinical Signs, Symptoms or Conditions, No Patient Involvement, No Consequences Or Impact To Patient, Poor Quality Image, No Known Impact Or Consequence To Patient, Detachment of Device or Device Component, Defective Device 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