MAUDE manufacturer profile

OLYMPUS MEDICAL SYSTEMS CORP. · FET

MAUDE profile for Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Key facts

Manufacturer OLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer group SHIRAKAWA OLYMPUS CO., LTD.
Product code FET
Product code name Endoscopic Video Imaging System/Component, Gastroenterology-Urology

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, No Display/Image, No Consequences Or Impact To Patient, No Patient Involvement, Communication or Transmission Problem, Electrical /Electronic Property Problem, Erratic or Intermittent Display, Poor Quality Image 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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