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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
2017 124 124
2018 158 158
2019 78 78
2020 78 78
2021 126 126
2022 169 169
2023 67 67
2024 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 473 473
Adverse Event Without Identified Device or Use Problem 246 246
Use of Device Problem 36 36
Insufficient Information 30 30
Device Operates Differently Than Expected 14 14
Therapeutic or Diagnostic Output Failure 11 11
Device Displays Incorrect Message 7 7
Human Factors Issue 6 6
Application Program Problem: Parameter Calculation Error 6 6
Appropriate Term/Code Not Available 6 6
Incomplete or Inadequate Connection 4 4
Defective Component 4 4
Loose or Intermittent Connection 4 4
Mechanical Problem 3 3
Device Issue 3 3
Improper Device Output 3 3
Inadequate User Interface 3 3
Programming Issue 3 3
Leak/Splash 3 3
Device Operational Issue 3 3
Defective Device 3 3
Contamination of Device Ingredient or Reagent 2 2
Mechanical Jam 2 2
Output Problem 2 2
Incorrect Or Inadequate Test Results 2 2
Device Maintenance Issue 2 2
No Apparent Adverse Event 2 2
Missing Value Reason 2 2
Unintended Movement 1 1
Device Emits Odor 1 1
Component Incompatible 1 1
Degraded 1 1
Electrical /Electronic Property Problem 1 1
Flushing Problem 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Unexpected Therapeutic Results 1 1
Device Inoperable 1 1
Installation-Related Problem 1 1
Material Deformation 1 1
Device Sensing Problem 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 217 217
No Clinical Signs, Symptoms or Conditions 176 176
No Consequences Or Impact To Patient 172 172
No Code Available 150 150
Tissue Damage 47 47
Injury 33 33
No Known Impact Or Consequence To Patient 23 23
Tissue Breakdown 16 16
Distress 10 10
No Information 5 5
Complaint, Ill-Defined 4 4
Chemical Exposure 3 3
Misdiagnosis 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unspecified Tissue Injury 2 2
Patient Problem/Medical Problem 2 2
Pain 2 2
Respiratory Distress 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LEICA BIOSYSTEMS NUSSLOCH GMBH II Dec-20-2023
2 Leica Microsystems, Inc. II Jul-03-2017
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