MAUDE manufacturer profile
DORNIER MEDTECH AMERICA INC · GEX
MAUDE profile for Powered Laser Surgical Instrument
Key facts
| Manufacturer | DORNIER MEDTECH AMERICA INC |
|---|---|
| Manufacturer group | DORNIER MEDTECH AMERICA INC. |
| Product code | GEX |
| Product code name | Powered Laser Surgical Instrument |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Apparent Adverse Event, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Fracture, Break, No Information, No Consequences Or Impact To Patient, Thermal Decomposition of Device 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