MAUDE manufacturer profile

MONTERIS MEDICAL · GEX

MAUDE profile for Powered Laser Surgical Instrument

Key facts

Manufacturer MONTERIS MEDICAL
Manufacturer group MONTERIS MEDICAL
Product code GEX
Product code name Powered Laser Surgical Instrument

At a glance

  • 100–999 MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, Computer Software Problem, Device Operational Issue, No Clinical Signs, Symptoms or Conditions, Melted, Neurological Deficit/Dysfunction 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

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