MAUDE manufacturer profile
SHIRAKAWA OLYMPUS CO., LTD. · GCT
MAUDE profile for Light Source, Endoscope, Xenon Arc
Key facts
| Manufacturer | SHIRAKAWA OLYMPUS CO., LTD. |
|---|---|
| Manufacturer group | SHIRAKAWA OLYMPUS CO., LTD. |
| Product code | GCT |
| Product code name | Light Source, Endoscope, Xenon Arc |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Display/Image, No Device Output, Poor Quality Image, Erratic or Intermittent Display, Electrical /Electronic Property Problem, No Visual Prompts/Feedback, Failure to Power Up 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