MAUDE manufacturer profile

SHIRAKAWA OLYMPUS CO., LTD. · PSV

MAUDE profile for Ultrasound Bronchoscope

Key facts

Manufacturer SHIRAKAWA OLYMPUS CO., LTD.
Manufacturer group SHIRAKAWA OLYMPUS CO., LTD.
Product code PSV
Product code name Ultrasound Bronchoscope

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, No Display/Image, Detachment of Device or Device Component, Failure to Clean Adequately, Communication or Transmission Problem, Poor Quality Image, Device Reprocessing Problem, Break 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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