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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
2014 84 84
2015 106 106
2016 124 124
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 586 586
Adverse Event Without Identified Device or Use Problem 380 380
Device Operates Differently Than Expected 56 56
Use of Device Problem 55 55
Insufficient Information 42 42
Appropriate Term/Code Not Available 29 29
Device Displays Incorrect Message 25 25
Therapeutic or Diagnostic Output Failure 14 14
Product Quality Problem 9 9
Failure to Cycle 7 7
Mechanical Problem 7 7
Output below Specifications 7 7
Human Factors Issue 6 6
Application Program Problem: Parameter Calculation Error 6 6
Leak/Splash 6 6
Incorrect Or Inadequate Test Results 6 6
Failure to Obtain Sample 6 6
Defective Component 4 4
Loose or Intermittent Connection 4 4
Incomplete or Inadequate Connection 4 4
Programming Issue 3 3
No Apparent Adverse Event 3 3
Device Operational Issue 3 3
Improper Device Output 3 3
Inadequate User Interface 3 3
Fluid/Blood Leak 3 3
Device Issue 3 3
Defective Device 3 3
Failure to Cut 2 2
Device Maintenance Issue 2 2
Electrical /Electronic Property Problem 2 2
Break 2 2
Component Falling 2 2
Output Problem 2 2
Computer Operating System Problem 2 2
Contamination of Device Ingredient or Reagent 2 2
Device Ingredient or Reagent Problem 2 2
Material Integrity Problem 2 2
Mechanical Jam 2 2
Missing Value Reason 2 2
Device Handling Problem 1 1
Unintended Movement 1 1
Human-Device Interface Problem 1 1
Device Sensing Problem 1 1
Difficult to Open or Close 1 1
Physical Property Issue 1 1
Pressure Problem 1 1
Installation-Related Problem 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Material Deformation 1 1
Component Incompatible 1 1
Contamination 1 1
Device Reprocessing Problem 1 1
Detachment Of Device Component 1 1
Filling Problem 1 1
Degraded 1 1
Flushing Problem 1 1
Device Alarm System 1 1
Device Emits Odor 1 1
Contamination /Decontamination Problem 1 1
Difficult to Remove 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Failure to Sense 1 1
Material Separation 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1
Device Inoperable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 258 258
No Code Available 246 246
Insufficient Information 217 217
No Clinical Signs, Symptoms or Conditions 176 176
Tissue Damage 102 105
No Known Impact Or Consequence To Patient 83 83
Injury 75 78
No Information 17 17
Tissue Breakdown 16 16
Distress 10 10
Complaint, Ill-Defined 5 5
Chemical Exposure 5 5
Patient Problem/Medical Problem 4 4
Misdiagnosis 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unspecified Tissue Injury 2 2
Laceration(s) 2 2
Pain 2 2
Test Result 2 2
Missing Value Reason 1 1
Respiratory Distress 1 1
Asthma 1 1
Atrial Fibrillation 1 1
Eye Injury 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
3 Leica Microsystems, Inc. II Sep-22-2015
4 Leica Microsystems, Inc. III Sep-17-2015
5 Leica Microsystems, Inc. II Jul-29-2013
6 Leica Microsystems, Inc. II Apr-27-2012
7 Leica Microsystems, Inc. II Jun-20-2011
8 Leica Microsystems, Inc. II May-07-2010
9 Thermo Fisher Scientific II Apr-12-2010
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