TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
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

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