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
Regulation Description Automated tissue processor.
Product CodeIEO
Regulation Number 864.3875
Device Class 1

MDR Year MDR Reports MDR Events
2020 78 78
2021 126 126
2022 169 169
2023 67 67
2024 63 63
2025 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Improper or Incorrect Procedure or Method 387 387
Adverse Event Without Identified Device or Use Problem 42 42
Insufficient Information 33 33
Use of Device Problem 32 32
Therapeutic or Diagnostic Output Failure 5 5
Incomplete or Inadequate Connection 4 4
Defective Component 4 4
Loose or Intermittent Connection 4 4
Defective Device 3 3
Leak/Splash 2 2
Output Problem 2 2
Application Program Problem: Parameter Calculation Error 2 2
No Apparent Adverse Event 2 2
Circuit Failure 1 1
Contamination 1 1
Contamination /Decontamination Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Material Deformation 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Sensing Problem 1 1
Flushing Problem 1 1
Unexpected Therapeutic Results 1 1
Mechanical Jam 1 1
Inadequate User Interface 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 235 235
No Clinical Signs, Symptoms or Conditions 196 196
No Consequences Or Impact To Patient 28 28
Tissue Breakdown 16 16
No Code Available 8 8
Tissue Damage 8 8
No Known Impact Or Consequence To Patient 6 6
Injury 5 5
Unspecified Tissue Injury 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Chemical Exposure 3 3
Distress 3 3
Conjunctivitis 2 2
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
-
-