MAUDE manufacturer profile

OLYMPUS MEDICAL SYSTEMS CORPORATION · FDS

MAUDE profile for Gastroscope And Accessories, Flexible/Rigid

Key facts

Manufacturer OLYMPUS MEDICAL SYSTEMS CORPORATION
Manufacturer group OLYMPUS MEDICAL SYSTEMS CORPORATION
Product code FDS
Product code name Gastroscope 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, Device Contamination with Chemical or Other Material, Failure to Clean Adequately, 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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