MAUDE manufacturer profile

OLYMPUS AMERICA, INC · GCJ

MAUDE profile for Laparoscope, General & Plastic Surgery

Key facts

Manufacturer OLYMPUS AMERICA, INC
Manufacturer group OLYMPUS AMERICA, INC
Product code GCJ
Product code name Laparoscope, General & Plastic Surgery

At a glance

  • 1–9 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • Device Damaged by Another Device, Failure to Fire, Break, Injury, No Information, No Clinical Signs, Symptoms or Conditions 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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