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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 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
  1.  K220345  STERLINK mini Sterilizer with STERLOAD mini Casset ...
  2.  K223015  STERLINK™ FPS-15s Plus sterilizer with STERPACK™ p ...
  3.  K231169  STERLINK plus Sterilizer with STERLOAD Cassette, T ...
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 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Environmental Particulates 305 305
Device Emits Odor 255 255
Smoking 69 69
Use of Device Problem 53 53
Device Handling Problem 21 21
Fluid/Blood Leak 18 18
Leak/Splash 15 15
Adverse Event Without Identified Device or Use Problem 14 14
Insufficient Information 14 14
Fire 8 8
Improper or Incorrect Procedure or Method 8 8
Gas/Air Leak 7 7
Appropriate Term/Code Not Available 6 6
Pressure Problem 4 4
Chemical Problem 3 3
Patient-Device Incompatibility 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
Excessive Heating 1 1
Ejection Problem 1 1
Expiration Date Error 1 1
Moisture or Humidity Problem 1 1
Material Integrity Problem 1 1
Failure to Align 1 1
Device Reprocessing Problem 1 1
No Apparent Adverse Event 1 1
Defective Component 1 1
Failure to Calibrate 1 1
Sparking 1 1
Shipping Damage or Problem 1 1
Failure to Cycle 1 1
Output Problem 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 407 407
No Consequences Or Impact To Patient 169 169
Burn(s) 58 58
Insufficient Information 27 27
Skin Discoloration 19 19
Skin Irritation 14 14
Headache 13 13
Skin Burning Sensation 12 12
Burning Sensation 9 9
Superficial (First Degree) Burn 5 5
Itching Sensation 5 5
Eye Burn 4 4
Unspecified Respiratory Problem 4 4
Dyspnea 4 4
Burn, Thermal 4 4
Dizziness 4 4
Red Eye(s) 3 3
Caustic/Chemical Burns 3 3
Irritation 3 3
Eye Pain 3 3
Nausea 3 3
Pain 3 3
No Code Available 3 3
No Known Impact Or Consequence To Patient 2 2
Swelling/ Edema 2 2
Injury 2 2
Cough 2 2
Swelling 1 1
Sore Throat 1 1
Damage to Ligament(s) 1 1
Rash 1 1
Reaction to Medicinal Component of Device 1 1
Reaction 1 1
Bone Fracture(s) 1 1
Fever 1 1
Hematoma 1 1
Pneumonia 1 1
Blurred Vision 1 1
High Blood Pressure/ Hypertension 1 1
Skin Inflammation/ Irritation 1 1
Discomfort 1 1
Erythema 1 1
Tachycardia 1 1
Unspecified Eye / Vision Problem 1 1

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