MAUDE manufacturer profile
EL.EN. ELECTRONIC ENGINEERING S.P.A. · GEX
MAUDE profile for Powered Laser Surgical Instrument
Key facts
| Manufacturer | EL.EN. ELECTRONIC ENGINEERING S.P.A. |
|---|---|
| Manufacturer group | EL.EN. ELECTRONIC ENGINEERING S.P.A. |
| Product code | GEX |
| Product code name | Powered Laser Surgical Instrument |
At a glance
- 100–999 MAUDE reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Pain, Burn(s), Scar Tissue, Improper or Incorrect Procedure or Method, Insufficient Information, Use of Device Problem, No Clinical Signs, Symptoms or Conditions 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