MAUDE manufacturer profile

COVIDIEN · OCW

MAUDE profile for Endoscopic Tissue Approximation Device

Key facts

Manufacturer COVIDIEN
Manufacturer group COVIDIEN
Product code OCW
Product code name Endoscopic Tissue Approximation Device

At a glance

  • 100–999 MAUDE reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Break, No Consequences Or Impact To Patient, No Clinical Signs, Symptoms or Conditions, Insufficient Information, Device Operates Differently Than Expected, Detachment of Device or Device Component, Detachment Of Device Component 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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