TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ADVANCED STERILIZATION PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
PLASMAPP CO,.LTD
	SUBSTANTIALLY EQUIVALENT	1
PLASMAPP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
STERILUCENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
STERIS
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Environmental Particulates	591	591
Device Emits Odor	407	407
Smoking	70	70
Adverse Event Without Identified Device or Use Problem	60	60
Use of Device Problem	29	29
Fluid/Blood Leak	23	23
Device Handling Problem	20	20
Appropriate Term/Code Not Available	17	17
Improper or Incorrect Procedure or Method	11	11
Chemical Problem	10	10
Fire	9	9
Leak/Splash	8	8
Gas/Air Leak	7	7
Insufficient Information	7	7
Patient-Device Incompatibility	5	5
Pressure Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Moisture or Humidity Problem	2	2
Chemical Spillage	2	2
Expiration Date Error	2	2
Fumes or Vapors	2	2
Fogging	2	2
Break	2	2
Thermal Decomposition of Device	2	2
Failure to Cycle	2	2
Degraded	2	2
Material Discolored	1	1
Device Reprocessing Problem	1	1
Mechanical Problem	1	1
Defective Component	1	1
Residue After Decontamination	1	1
Failure to Align	1	1
Overheating of Device	1	1
Increase in Pressure	1	1
Shipping Damage or Problem	1	1
Device Displays Incorrect Message	1	1
Inadequate or Insufficient Training	1	1
Device Operates Differently Than Expected	1	1
Electrical Power Problem	1	1
Temperature Problem	1	1
Output Problem	1	1
Material Integrity Problem	1	1
No Apparent Adverse Event	1	1
Noise, Audible	1	1
Ejection Problem	1	1
Excessive Heating	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	552	552
No Clinical Signs, Symptoms or Conditions	387	387
Burn, Thermal	49	49
Burning Sensation	31	31
Skin Irritation	28	28
Burn(s)	27	27
Headache	27	27
Insufficient Information	27	27
No Code Available	23	23
No Known Impact Or Consequence To Patient	18	18
Irritation	16	16
Itching Sensation	14	14
Skin Burning Sensation	10	10
Skin Discoloration	8	8
Nausea	7	7
Dizziness	6	6
Caustic/Chemical Burns	6	6
Superficial (First Degree) Burn	5	5
Eye Burn	4	4
Red Eye(s)	4	4
Dyspnea	4	4
Unspecified Respiratory Problem	3	3
Eye Pain	3	3
Cough	2	2
Chemical Exposure	2	2
Injury	2	2
Sore Throat	1	1
Reaction	1	1
Chest Tightness/Pressure	1	1
Discomfort	1	1
Unspecified Eye / Vision Problem	1	1
Skin Inflammation/ Irritation	1	1
Reaction to Medicinal Component of Device	1	1
Fever	1	1
High Blood Pressure/ Hypertension	1	1
Pneumonia	1	1
Rash	1	1
Swelling	1	1
Tachycardia	1	1
Blurred Vision	1	1