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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 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 412 412
Adverse Event Without Identified Device or Use Problem 55 55
Use of Device Problem 28 28
Insufficient Information 19 19
Therapeutic or Diagnostic Output Failure 7 7
Incomplete or Inadequate Connection 4 4
Application Program Problem: Parameter Calculation Error 4 4
Loose or Intermittent Connection 4 4
Defective Component 4 4
Defective Device 3 3
Inadequate User Interface 3 3
Output Problem 2 2
Mechanical Problem 2 2
Leak/Splash 2 2
Appropriate Term/Code Not Available 2 2
Mechanical Jam 2 2
No Apparent Adverse Event 2 2
Unintended Movement 1 1
Unexpected Therapeutic Results 1 1
Electrical /Electronic Property Problem 1 1
Flushing Problem 1 1
Material Deformation 1 1
Contamination /Decontamination Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Sensing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 211 211
No Clinical Signs, Symptoms or Conditions 175 175
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
Chemical Exposure 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unspecified Tissue Injury 2 2
Pain 2 2
Respiratory Distress 1 1

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