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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sterilizer, chemical
Product CodeMLR
Regulation Number 880.6860
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED STERILIZATION PRODUCTS
  SUBSTANTIALLY EQUIVALENT 7
ADVANCED STERILIZATION PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PLASMAPP CO,.LTD
  SUBSTANTIALLY EQUIVALENT 1
PLASMAPP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
STERILUCENT, INC
  SUBSTANTIALLY EQUIVALENT 1
STERILUCENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 16

MDR Year MDR Reports MDR Events
2014 399 399
2015 412 412
2016 286 286
2017 279 279
2018 289 289
2019 222 222
2020 174 174
2021 202 202
2022 188 188
2023 140 140
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Device Emits Odor 1165 1165
Environmental Particulates 880 880
Appropriate Term/Code Not Available 204 204
Adverse Event Without Identified Device or Use Problem 93 93
Smoking 79 79
Chemical Problem 61 61
Device Handling Problem 46 46
Use of Device Problem 42 42
Chemical Spillage 39 39
Insufficient Information 39 39
Fluid/Blood Leak 31 31
Improper or Incorrect Procedure or Method 28 28
Leak/Splash 12 12
Fire 10 10
Device Operates Differently Than Expected 9 9
Gas/Air Leak 7 7
Patient-Device Incompatibility 6 6
Device Disinfection Or Sterilization Issue 6 6
Fumes or Vapors 5 5
Device Displays Incorrect Message 5 5
Break 5 5
Pressure Problem 5 5
Contamination /Decontamination Problem 4 4
Thermal Decomposition of Device 3 3
Moisture or Humidity Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Output Problem 2 2
Noise, Audible 2 2
Fogging 2 2
Failure to Cycle 2 2
Degraded 2 2
Overheating of Device 2 2
Expiration Date Error 2 2
Mechanical Problem 2 2
Device Damaged Prior to Use 1 1
Defective Component 1 1
Residue After Decontamination 1 1
Failure to Align 1 1
Communication or Transmission Problem 1 1
Increase in Pressure 1 1
Shipping Damage or Problem 1 1
Problem with Sterilization 1 1
Inadequate or Insufficient Training 1 1
Device Inoperable 1 1
Material Discolored 1 1
Electrical /Electronic Property Problem 1 1
Device Expiration Issue 1 1
Device Reprocessing Problem 1 1
Ejection Problem 1 1
Excessive Heating 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Temperature Problem 1 1
Ventilation Problem in Device Environment 1 1
No Apparent Adverse Event 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Operating System Version or Upgrade Problem 1 1
Device Unsafe to Use in Environment 1 1
Electrical Power Problem 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 750 750
No Consequences Or Impact To Patient 673 673
No Clinical Signs, Symptoms or Conditions 402 402
No Known Impact Or Consequence To Patient 219 219
Skin Irritation 118 118
Burn(s) 87 87
Headache 81 81
No Code Available 79 79
Burning Sensation 52 52
Burn, Thermal 49 49
Irritation 41 41
Insufficient Information 27 27
Itching Sensation 24 24
Skin Discoloration 18 18
Caustic/Chemical Burns 17 17
Red Eye(s) 14 14
Nausea 14 14
Dizziness 11 11
No Information 10 10
Skin Burning Sensation 10 10
Sore Throat 7 7
Respiratory Distress 7 7
Superficial (First Degree) Burn 5 5
Injury 4 4
Eye Burn 4 4
Chemical Exposure 4 4
Chest Pain 4 4
Corneal Decompensation 4 4
Dyspnea 4 4
Corneal Edema 3 3
Inflammation 3 3
Tingling 3 3
Swelling 3 3
Chest Tightness/Pressure 3 3
Unspecified Respiratory Problem 3 3
Eye Pain 3 3
Cough 2 2
Meningitis 2 2
Discomfort 2 2
Sneezing 2 2
Bacterial Infection 2 2
Asthma 1 1
Fever 1 1
Laceration(s) 1 1
Damage to Ligament(s) 1 1
Hemoptysis 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Urticaria 1 1
Tachycardia 1 1
Blurred Vision 1 1
Pain 1 1
Pneumonia 1 1
Rash 1 1
Complaint, Ill-Defined 1 1
Reaction 1 1
Numbness 1 1
Sweating 1 1
Palpitations 1 1
Bronchospasm 1 1
Unspecified Eye / Vision Problem 1 1
Partial thickness (Second Degree) Burn 1 1
Skin Inflammation/ Irritation 1 1
Reaction to Medicinal Component of Device 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Sterilization Products II Feb-14-2017
2 Advanced Sterilization Products II Aug-13-2015
3 Advanced Sterilization Products II Dec-22-2014
4 Advanced Sterilization Products II Jan-14-2014
5 Advanced Sterilization Products II Nov-26-2013
6 Advanced Sterilization Products II Nov-08-2013
7 Advanced Sterilization Products II Oct-22-2013
8 Advanced Sterilization Products II Oct-22-2013
9 Advanced Sterilization Products II Sep-10-2013
10 Advanced Sterilization Products II Mar-30-2013
11 Advanced Sterilization Products II Mar-26-2013
12 Advanced Sterilization Products II Jan-09-2013
13 Advanced Sterilization Products III Sep-07-2012
14 Advanced Sterilization Products II Jan-13-2012
15 Advanced Sterilization Products II Jan-11-2012
16 Advanced Sterilization Products II Jun-30-2009
17 Advanced Sterilization Products II Jun-15-2009
18 Steris Corporation II Aug-31-2018
19 Steris Corporation II Feb-13-2018
20 Steris Corporation II Dec-31-2013
21 Steris Corporation II Sep-20-2012
22 Steris Corporation II Sep-01-2011
23 Steris Corporation II Aug-19-2011
24 Steris Corporation III Dec-28-2010
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