MAUDE manufacturer profile
SHIRAKAWA OLYMPUS CO., LTD. · GEI
MAUDE profile for Electrosurgical, Cutting & Coagulation & Accessories
Key facts
| Manufacturer | SHIRAKAWA OLYMPUS CO., LTD. |
|---|---|
| Manufacturer group | SHIRAKAWA OLYMPUS CO., LTD. |
| Product code | GEI |
| Product code name | Electrosurgical, Cutting & Coagulation & Accessories |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Output above Specifications, Hemorrhage/Blood Loss/Bleeding, Device Emits Odor, Energy Output Problem, Sparking, Electrical /Electronic Property Problem 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