MAUDE manufacturer profile
LUMENIS LTD · GEX
MAUDE profile for Powered Laser Surgical Instrument
Key facts
| Manufacturer | LUMENIS LTD |
|---|---|
| Manufacturer group | LUMENIS LTD |
| Product code | GEX |
| Product code name | Powered Laser Surgical Instrument |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Break, Adverse Event Without Identified Device or Use Problem, Burn(s), Defective Device, No Known Impact Or Consequence To Patient, Device Displays Incorrect Message, Output below Specifications 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