MAUDE manufacturer profile

OLYMPUS MEDICAL SYSTEMS CORP. · FDT

MAUDE profile for Duodenoscope And Accessories, Flexible/Rigid

Key facts

Manufacturer OLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer group AIZU OLYMPUS CO., LTD.
Product code FDT
Product code name Duodenoscope 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 Consequences Or Impact To Patient, Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, Break, Device Contamination with Chemical or Other Material, Contamination 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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