MAUDE manufacturer profile
QUANTA SYSTEM S.P.A. · GEX
MAUDE profile for Powered Laser Surgical Instrument
Key facts
| Manufacturer | QUANTA SYSTEM S.P.A. |
|---|---|
| Manufacturer group | QUANTA SYSTEM S.P.A. |
| Product code | GEX |
| Product code name | Powered Laser Surgical Instrument |
At a glance
- 1,000+ MAUDE reports
- 1–9 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Therapeutic or Diagnostic Output Failure, Output Problem, Device Operates Differently Than Expected, No Consequences Or Impact To Patient, Defective Device, Appropriate Term/Code Not Available 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