MAUDE manufacturer profile

STRYKER ENDOSCOPY-SAN JOSE · HIF

MAUDE profile for Insufflator, Laparoscopic

Key facts

Manufacturer STRYKER ENDOSCOPY-SAN JOSE
Manufacturer group STRYKER ENDOSCOPY-SAN JOSE
Product code HIF
Product code name Insufflator, Laparoscopic

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Pressure Problem, Insufficient Information, Adverse Event Without Identified Device or Use Problem, Increase in Pressure, Device Operates Differently Than Expected, Decrease in Pressure 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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