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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sterilizer, chemical
Regulation Description Ethylene oxide gas sterilizer.
Product CodeMLR
Regulation Number 880.6860
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 4
ADVANCED STERILIZATION PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PLASMAPP CO,.LTD
  SUBSTANTIALLY EQUIVALENT 1
STERILUCENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 7

MDR Year MDR Reports MDR Events
2016 286 286
2017 279 279
2018 289 289
2019 222 222
2020 174 174
2021 168 168

Device Problems MDRs with this Device Problem Events in those MDRs
Environmental Particulates 638 638
Device Emits Odor 518 518
Adverse Event Without Identified Device or Use Problem 84 84
Smoking 71 71
Device Handling Problem 38 38
Chemical Spillage 36 36
Appropriate Term/Code Not Available 30 30
Chemical Problem 27 27
Fluid Leak 24 24
Improper or Incorrect Procedure or Method 20 20
Insufficient Information 17 17
Leak/Splash 8 8
Fire 7 7
Gas Leak 7 7
Device Disinfection Or Sterilization Issue 6 6
Device Operates Differently Than Expected 6 6
Patient-Device Incompatibility 6 6
Contamination /Decontamination Problem 4 4
Use of Device Problem 4 4
Break 3 3
Thermal Decomposition of Device 3 3
Device Displays Incorrect Message 3 3
Therapeutic or Diagnostic Output Failure 3 3
Moisture or Humidity Problem 2 2
Expiration Date Error 2 2
Fumes or Vapors 2 2
Degraded 2 2
Mechanical Problem 2 2
Fogging 2 2
Material Discolored 1 1
Electrical /Electronic Property Problem 1 1
Failure to Cycle 1 1
Overheating of Device 1 1
Increase in Pressure 1 1
Problem with Sterilization 1 1
Inadequate or Insufficient Training 1 1
Device Inoperable 1 1
Defective Component 1 1
Residue After Decontamination 1 1
Failure to Align 1 1
Material Protrusion/Extrusion 1 1
Device Unsafe to Use in Environment 1 1
Electrical Power Problem 1 1
Ventilation Problem in Device Environment 1 1
Operating System Version or Upgrade Problem 1 1
Output Problem 1 1
Positioning Problem 1 1
Pressure Problem 1 1
Temperature Problem 1 1
Noise, Audible 1 1
Excessive Heating 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 655 655
No Patient Involvement 278 278
No Clinical Signs, Symptoms or Conditions 99 99
Skin Irritation 77 77
No Known Impact Or Consequence To Patient 51 51
Burn, Thermal 49 49
Headache 47 47
Burning Sensation 43 43
No Code Available 42 42
Burn(s) 36 36
Irritation 27 27
Insufficient Information 24 24
Itching Sensation 19 19
Red Eye(s) 12 12
Nausea 9 9
Dizziness 9 9
Caustic/Chemical Burns 8 8
Respiratory Distress 6 6
Skin Discoloration 5 5
Superficial (First Degree) Burn 5 5
Injury 4 4
Corneal Decompensation 4 4
No Information 4 4
Eye Pain 3 3
Corneal Edema 3 3
Inflammation 3 3
Chemical Exposure 3 3
Swelling 3 3
Sneezing 2 2
Meningitis 2 2
Sore Throat 2 2
Bacterial Infection 2 2
Dyspnea 2 2
Chest Pain 2 2
Skin Burning Sensation 2 2
Reaction to Medicinal Component of Device 1 1
Unspecified Eye / Vision Problem 1 1
Cough 1 1
Partial thickness (Second Degree) Burn 1 1
Hemoptysis 1 1
High Blood Pressure/ Hypertension 1 1
Fever 1 1
Laceration(s) 1 1
Pneumonia 1 1
Reaction 1 1
Sweating 1 1
Chest Tightness/Pressure 1 1
Complaint, Ill-Defined 1 1
Tingling 1 1
Tachycardia 1 1
Blurred Vision 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Sterilization Products II Feb-14-2017
2 Steris Corporation II Aug-31-2018
3 Steris Corporation II Feb-13-2018
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