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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device fibrin sealant preparation device
Product CodeMZM
Regulation Number 880.5860
Device Class 2


Premarket Reviews
ManufacturerDecision
ETHICON INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 6 6
2020 38 38
2021 26 26
2022 103 103
2023 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Disconnect 100 100
Appropriate Term/Code Not Available 46 46
Break 33 33
Material Separation 14 14
Material Integrity Problem 6 6
Connection Problem 5 5
Detachment of Device or Device Component 4 4
Difficult to Open or Close 3 3
Activation Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Physical Resistance/Sticking 2 2
Component Misassembled 2 2
Difficult to Remove 2 2
Contamination /Decontamination Problem 2 2
Separation Failure 1 1
Defective Device 1 1
Excessive Cooling 1 1
Failure of Device to Self-Test 1 1
Improper Flow or Infusion 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Deformation 1 1
Defective Component 1 1
Component Missing 1 1
Misfire 1 1
Complete Blockage 1 1
Coagulation in Device or Device Ingredient 1 1
Contamination 1 1
Leak/Splash 1 1
Material Too Soft/Flexible 1 1
Ejection Problem 1 1
Firing Problem 1 1
Activation, Positioning or Separation Problem 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Incomplete or Inadequate Connection 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 163 163
No Consequences Or Impact To Patient 29 29
Insufficient Information 5 5

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