MAUDE manufacturer profile

OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT · FDT

MAUDE profile for Duodenoscope And Accessories, Flexible/Rigid

Key facts

Manufacturer OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
Manufacturer group OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
Product code FDT
Product code name Duodenoscope And Accessories, Flexible/Rigid

At a glance

  • 100–999 MAUDE reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Detachment of Device or Device Component, No Clinical Signs, Symptoms or Conditions, Foreign Body In Patient, Break, Unspecified Tissue Injury, Separation Problem, Contamination, Crack 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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