MAUDE manufacturer profile

AOMORI OLYMPUS CO., LTD. · PTS

MAUDE profile for Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Key facts

Manufacturer AOMORI OLYMPUS CO., LTD.
Manufacturer group AOMORI OLYMPUS CO., LTD.
Product code PTS
Product code name Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

At a glance

  • 100–999 MAUDE reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Difficult to Open or Remove Packaging Material, Packaging Problem, Device Reprocessing Problem, Tear, Rip or Hole in Device Packaging, Difficult to Remove, Difficult to Open or Close, Failure to Clean Adequately 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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