MAUDE manufacturer profile

AOMORI OLYMPUS CO., LTD. · FBK

MAUDE profile for Endoscopic Injection Needle, Gastroenterology-Urology

Key facts

Manufacturer AOMORI OLYMPUS CO., LTD.
Manufacturer group AOMORI OLYMPUS CO., LTD.
Product code FBK
Product code name Endoscopic Injection Needle, Gastroenterology-Urology

At a glance

  • 100–999 MAUDE reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Failure to Deliver, No Flow, Infusion or Flow Problem, Activation Failure, Failure to Infuse, Mechanical Problem, Physical Resistance/Sticking 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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