Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 598 598
Adverse Event Without Identified Device or Use Problem 380 380
Use of Device Problem 56 56
Device Operates Differently Than Expected 56 56
Insufficient Information 47 47
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
Failure to Obtain Sample 6 6
Application Program Problem: Parameter Calculation Error 6 6
Leak/Splash 6 6
Incorrect Or Inadequate Test Results 6 6
Human Factors Issue 6 6
Defective Component 4 4
Loose or Intermittent Connection 4 4
Incomplete or Inadequate Connection 4 4
Defective Device 3 3
No Apparent Adverse Event 3 3
Programming Issue 3 3
Device Issue 3 3
Improper Device Output 3 3
Device Operational Issue 3 3
Fluid/Blood Leak 3 3
Inadequate User Interface 3 3
Missing Value Reason 2 2
Contamination of Device Ingredient or Reagent 2 2
Failure to Cut 2 2
Device Maintenance Issue 2 2
Contamination 2 2
Break 2 2
Output Problem 2 2
Component Falling 2 2
Computer Operating System Problem 2 2
Device Ingredient or Reagent Problem 2 2
Mechanical Jam 2 2
Electrical /Electronic Property Problem 2 2
Material Integrity Problem 2 2
Component Incompatible 1 1
Difficult to Open or Close 1 1
Device Inoperable 1 1
Detachment Of Device Component 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Device Handling Problem 1 1
Material Deformation 1 1
Use of Incorrect Control/Treatment Settings 1 1
Unintended Movement 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 225 225
No Clinical Signs, Symptoms or Conditions 186 186
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Misdiagnosis 3 3
Unspecified Tissue Injury 3 3
Test Result 2 2
Laceration(s) 2 2
Pain 2 2
Respiratory Distress 1 1
Atrial Fibrillation 1 1
Asthma 1 1
Eye Injury 1 1
Missing Value Reason 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
3 Leica Microsystems, Inc. II Jul-03-2017
4 Leica Microsystems, Inc. II Sep-22-2015
5 Leica Microsystems, Inc. III Sep-17-2015
6 Leica Microsystems, Inc. II Jul-29-2013
7 Leica Microsystems, Inc. II Apr-27-2012
8 Leica Microsystems, Inc. II Jun-20-2011
9 Leica Microsystems, Inc. II May-07-2010
10 Thermo Fisher Scientific II Apr-12-2010
-
-