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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 1
ADVANCED STERILIZATION PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED STERILIZATION PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
IDEATE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
LOWTEM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PLASMAPP CO,.LTD
  SUBSTANTIALLY EQUIVALENT 1
PLASMAPP CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
STERIS
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 174 174
2021 202 202
2022 188 188
2023 140 140
2024 44 44
2025 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Environmental Particulates 305 305
Device Emits Odor 255 255
Smoking 70 70
Use of Device Problem 57 57
Leak/Splash 22 22
Device Handling Problem 22 22
Fluid/Blood Leak 18 18
Insufficient Information 16 16
Adverse Event Without Identified Device or Use Problem 15 15
Fire 11 11
Gas/Air Leak 8 8
Improper or Incorrect Procedure or Method 8 8
Appropriate Term/Code Not Available 6 6
Pressure Problem 4 4
Chemical Problem 3 3
Patient-Device Incompatibility 3 3
Material Integrity Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Fumes or Vapors 2 2
Device Damaged Prior to Use 2 2
Fogging 2 2
Thermal Decomposition of Device 2 2
Sparking 1 1
Mechanical Problem 1 1
Output Problem 1 1
Crack 1 1
Defective Component 1 1
Expiration Date Error 1 1
Ejection Problem 1 1
Shipping Damage or Problem 1 1
Failure to Align 1 1
Moisture or Humidity Problem 1 1
No Apparent Adverse Event 1 1
Failure to Calibrate 1 1
Excessive Heating 1 1
Device Reprocessing Problem 1 1
Failure to Cycle 1 1
Inadequate or Insufficient Training 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 418 418
No Consequences Or Impact To Patient 169 169
Burn(s) 66 66
Insufficient Information 27 27
Skin Discoloration 19 19
Skin Irritation 14 14
Headache 13 13
Skin Burning Sensation 12 12
Burning Sensation 10 10
Superficial (First Degree) Burn 5 5
Itching Sensation 5 5
Dizziness 4 4
Burn, Thermal 4 4
Unspecified Respiratory Problem 4 4
Eye Burn 4 4
Dyspnea 4 4
No Code Available 3 3
Nausea 3 3
Red Eye(s) 3 3
Eye Pain 3 3
Irritation 3 3
Caustic/Chemical Burns 3 3
Cough 3 3
Pain 3 3
No Known Impact Or Consequence To Patient 2 2
Injury 2 2
Swelling/ Edema 2 2
Sore Throat 1 1
Blurred Vision 1 1
Tachycardia 1 1
Pneumonia 1 1
Reaction 1 1
Erythema 1 1
Discomfort 1 1
Unspecified Eye / Vision Problem 1 1
Swelling 1 1
Rash 1 1
Fever 1 1
Reaction to Medicinal Component of Device 1 1
Hematoma 1 1
Bone Fracture(s) 1 1
Skin Inflammation/ Irritation 1 1
Damage to Ligament(s) 1 1
High Blood Pressure/ Hypertension 1 1

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