MAUDE manufacturer profile

OLYMPUS MEDICAL SYSTEMS CORP-SHIRAKAWA · FAJ

MAUDE profile for Cystoscope And Accessories, Flexible/Rigid

Key facts

Manufacturer OLYMPUS MEDICAL SYSTEMS CORP-SHIRAKAWA
Manufacturer group SHIRAKAWA OLYMPUS CO., LTD.
Product code FAJ
Product code name Cystoscope And Accessories, Flexible/Rigid

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Urinary Tract Infection, Fever, Pain 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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