MAUDE manufacturer profile
EP TECHNOLOGIES, INC. · GEX
MAUDE profile for Powered Laser Surgical Instrument
Key facts
| Manufacturer | EP TECHNOLOGIES, INC. |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| Product code | GEX |
| Product code name | Powered Laser Surgical Instrument |
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, Defective Device, Device Displays Incorrect Message, Output below Specifications, Adverse Event Without Identified Device or Use Problem, Material Integrity Problem, Insufficient Information, Break 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