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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device insufflator, endoscopic vessel harvesting
Definition To provide selected flow rates and pressures of co2 gas to separate tissue planes so the saphenous vein or radial artery can be isolated and ligated.
Product CodeOSV
Regulation Number 884.1730
Device Class 2

MDR Year MDR Reports MDR Events
2014 2 2
2015 2 2
2016 1 1
2019 1 1
2020 1 1
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Therapeutic or Diagnostic Output Failure 2 2
Bent 1 1
Break 1 1
Disconnection 1 1
Leak/Splash 1 1
Mechanical Problem 1 1
Loss of Power 1 1
Device Remains Activated 1 1
Defective Component 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Environmental Particulates 1 1
Infusion or Flow Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4 4
No Known Impact Or Consequence To Patient 3 3
Insufficient Information 3 3

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