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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device processor, tissue, automated
Product CodeIEO
Regulation Number 864.3875
Device Class 1

MDR Year MDR Reports MDR Events
2019 78 78
2020 78 78
2021 126 126
2022 169 169
2023 67 67
2024 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 426 426
Adverse Event Without Identified Device or Use Problem 56 56
Use of Device Problem 30 30
Insufficient Information 29 29
Therapeutic or Diagnostic Output Failure 7 7
Incomplete or Inadequate Connection 4 4
Defective Component 4 4
Application Program Problem: Parameter Calculation Error 4 4
Loose or Intermittent Connection 4 4
Defective Device 3 3
Inadequate User Interface 3 3
Leak/Splash 2 2
Output Problem 2 2
Mechanical Problem 2 2
Appropriate Term/Code Not Available 2 2
No Apparent Adverse Event 2 2
Mechanical Jam 2 2
Unintended Movement 1 1
Contamination 1 1
Contamination /Decontamination Problem 1 1
Material Deformation 1 1
Use of Incorrect Control/Treatment Settings 1 1
Flushing Problem 1 1
Unexpected Therapeutic Results 1 1
Device Sensing Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 225 225
No Clinical Signs, Symptoms or Conditions 186 186
No Consequences Or Impact To Patient 74 74
No Code Available 22 22
Tissue Damage 19 19
Tissue Breakdown 16 16
Injury 13 13
No Known Impact Or Consequence To Patient 12 12
Distress 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Chemical Exposure 3 3
Unspecified Tissue Injury 3 3
Pain 2 2
Respiratory Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LEICA BIOSYSTEMS NUSSLOCH GMBH II Jun-04-2024
2 LEICA BIOSYSTEMS NUSSLOCH GMBH II Dec-20-2023
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