MAUDE manufacturer profile
HOYA CORPORATION PENTAX TOKYO OFFICE · FDF
MAUDE profile for Colonoscope And Accessories, Flexible/Rigid
Key facts
| Manufacturer | HOYA CORPORATION PENTAX TOKYO OFFICE |
|---|---|
| Manufacturer group | HOYA CORPORATION PENTAX TOKYO OFFICE |
| Product code | FDF |
| Product code name | Colonoscope And Accessories, Flexible/Rigid |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Break, Optical Obstruction, Erratic or Intermittent Display, Fluid/Blood Leak, Obstruction of Flow, No Display/Image, Detachment of Device or Device Component 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