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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 2

MDR Year MDR Reports MDR Events
2019 6 6
2020 38 38
2021 26 26
2022 103 103
2023 47 47
2024 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Disconnect 128 128
Appropriate Term/Code Not Available 62 62
Break 33 33
Material Separation 14 14
Material Integrity Problem 8 8
Connection Problem 7 7
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
Device Markings/Labelling Problem 2 2
Difficult to Remove 2 2
Contamination /Decontamination Problem 2 2
Separation Failure 1 1
Defective Device 1 1
Activation, Positioning or Separation Problem 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
Incomplete or Inadequate Connection 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
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 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 199 199
No Consequences Or Impact To Patient 29 29
Insufficient Information 6 6

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