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	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

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