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	71	71
Use of Device Problem	59	59
Leak/Splash	25	25
Device Handling Problem	22	22
Fluid/Blood Leak	18	18
Insufficient Information	17	17
Adverse Event Without Identified Device or Use Problem	16	16
Fire	13	13
Gas/Air Leak	8	8
Improper or Incorrect Procedure or Method	8	8
Appropriate Term/Code Not Available	6	6
Pressure Problem	4	4
Material Integrity 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
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
Detachment of Device or Device Component	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	423	423
No Consequences Or Impact To Patient	169	169
Burn(s)	70	70
Insufficient Information	28	28
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
Unspecified Respiratory Problem	4	4
Eye Burn	4	4
Burn, Thermal	4	4
Dyspnea	4	4
Eye Pain	3	3
Nausea	3	3
Red Eye(s)	3	3
No Code Available	3	3
Caustic/Chemical Burns	3	3
Cough	3	3
Irritation	3	3
Pain	3	3
Swelling/ Edema	2	2
Injury	2	2
No Known Impact Or Consequence To Patient	2	2
Bone Fracture(s)	2	2
Swelling	1	1
Discomfort	1	1
Unspecified Eye / Vision Problem	1	1
Erythema	1	1
Rash	1	1
Pneumonia	1	1
Reaction	1	1
Tachycardia	1	1
Fever	1	1
Blurred Vision	1	1
Reaction to Medicinal Component of Device	1	1
Hematoma	1	1
Skin Inflammation/ Irritation	1	1
Sore Throat	1	1
Damage to Ligament(s)	1	1
High Blood Pressure/ Hypertension	1	1