MAUDE manufacturer profile

OLYMPUS MEDICAL SYSTEMS CORP. · FDF

MAUDE profile for Colonoscope And Accessories, Flexible/Rigid

Key facts

Manufacturer OLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer group AIZU OLYMPUS CO., LTD.
Product code FDF
Product code name Colonoscope And Accessories, Flexible/Rigid

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Microbial Contamination of Device, No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, Device Reprocessing Problem, Failure to Clean Adequately, Contamination, Adverse Event Without Identified Device or Use Problem 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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