MAUDE manufacturer profile
HOYA CORPORATION PENTAX TOKYO OFFICE · FDT
MAUDE profile for Duodenoscope And Accessories, Flexible/Rigid
Key facts
| Manufacturer | HOYA CORPORATION PENTAX TOKYO OFFICE |
|---|---|
| Manufacturer group | HOYA CORPORATION PENTAX TOKYO OFFICE |
| Product code | FDT |
| Product code name | Duodenoscope And Accessories, Flexible/Rigid |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Loss of or Failure to Bond, No Known Impact Or Consequence To Patient, Break, Fluid/Blood Leak, Optical Obstruction, Microbial Contamination of Device, 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