MAUDE manufacturer profile
HOYA CORPORATION PENTAX TOKYO OFFICE · FDS
MAUDE profile for Gastroscope And Accessories, Flexible/Rigid
Key facts
| Manufacturer | HOYA CORPORATION PENTAX TOKYO OFFICE |
|---|---|
| Manufacturer group | HOYA CORPORATION PENTAX TOKYO OFFICE |
| Product code | FDS |
| Product code name | Gastroscope And Accessories, Flexible/Rigid |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Break, Fluid/Blood Leak, Obstruction of Flow, Erratic or Intermittent Display, No Known Impact Or Consequence To Patient, Failure to Clean Adequately, Optical Obstruction 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