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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device endoscopic video imaging system/component, gastroenterology-urology
Definition To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
Product CodeOCS
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
STRYKER COMMUNICATIONS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 1 1
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 1 1
Component Incompatible 1 1
Device Operates Differently Than Expected 1 1
Problem with Software Installation 1 1
Intermittent Communication Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
No Known Impact Or Consequence To Patient 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Jul-20-2018
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