MAUDE manufacturer profile
PENTAX OF AMERICA, INC · FDS
MAUDE profile for Gastroscope And Accessories, Flexible/Rigid
Key facts
| Manufacturer | PENTAX OF AMERICA, INC |
|---|---|
| Manufacturer group | HOYA CORPORATION PENTAX TOKYO OFFICE |
| Product code | FDS |
| Product code name | Gastroscope And Accessories, Flexible/Rigid |
At a glance
- 1–9 MAUDE reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Optical Problem, Erratic or Intermittent Display, Difficult to Advance, Gas/Air Leak, Detachment Of Device Component, Contamination, Leak/Splash 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