TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BELIMED AG
	SUBSTANTIALLY EQUIVALENT	1
CONSOLIDATED MACHINE CORP.
	SUBSTANTIALLY EQUIVALENT	1
ENBIO GROUP AG
	SUBSTANTIALLY EQUIVALENT	2
FORT DEFIANCE INDUSTRIES LLC
	SUBSTANTIALLY EQUIVALENT	1
MAQUET GMBH
	SUBSTANTIALLY EQUIVALENT	2
MIDMARK CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PRIMUS STERILIZER COMPANY, LLC
	SUBSTANTIALLY EQUIVALENT	2
SCICAN LTD.
	SUBSTANTIALLY EQUIVALENT	4
SHINVA MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STEELCO S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
STERIS
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
STURDY INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
TUTTNAUER LTD.
	SUBSTANTIALLY EQUIVALENT	4
TUTTNAUER U.S.A CO, LTD
	SUBSTANTIALLY EQUIVALENT	1
W&H STERILIZATION S.R.L.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	112	112
Fluid/Blood Leak	58	58
Device Fell	57	57
Adverse Event Without Identified Device or Use Problem	30	30
Device Tipped Over	27	27
Detachment of Device or Device Component	22	22
Use of Device Problem	18	18
Insufficient Information	13	13
Problem with Software Installation	8	8
Pressure Problem	7	7
Sharp Edges	7	7
Unstable	6	6
Labelling, Instructions for Use or Training Problem	6	6
Device Handling Problem	6	6
Temperature Problem	5	5
Fire	5	5
Device Alarm System	5	5
Unintended Movement	5	5
Mechanical Problem	4	4
Flaked	4	4
Unintended System Motion	4	4
Device Dislodged or Dislocated	4	4
Smoking	4	4
Gas/Air Leak	4	4
Failure to Align	4	4
Improper or Incorrect Procedure or Method	3	3
Loose or Intermittent Connection	3	3
Protective Measures Problem	3	3
No Apparent Adverse Event	3	3
Product Quality Problem	3	3
Positioning Problem	3	3
Defective Device	3	3
Device Slipped	3	3
Moisture or Humidity Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Material Puncture/Hole	2	2
Material Separation	2	2
Overheating of Device	2	2
Difficult to Open or Close	2	2
Sparking	2	2
Noise, Audible	2	2
Shipping Damage or Problem	1	1
Positioning Failure	1	1
Unintended Ejection	1	1
Material Fragmentation	1	1
Contamination /Decontamination Problem	1	1
Contamination	1	1
Device Difficult to Maintain	1	1
Thermal Decomposition of Device	1	1
Particulates	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	191	191
No Known Impact Or Consequence To Patient	69	69
No Consequences Or Impact To Patient	38	38
Insufficient Information	33	33
Burn(s)	25	25
Injury	18	18
Pain	15	15
Burn, Thermal	14	14
Fall	7	7
Laceration(s)	6	6
Superficial (First Degree) Burn	4	4
No Information	3	3
Bone Fracture(s)	3	3
Partial thickness (Second Degree) Burn	3	3
Bruise/Contusion	3	3
Patient Problem/Medical Problem	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Unspecified Infection	2	2
No Code Available	2	2
Abrasion	2	2
Muscle/Tendon Damage	2	2
Unspecified Tissue Injury	2	2
Skin Tears	2	2
Dizziness	1	1
Inflammation	1	1
Unspecified Ear or Labyrinth Problem	1	1
No Patient Involvement	1	1
Discomfort	1	1
Ecchymosis	1	1
Hyperextension	1	1
Swelling/ Edema	1	1
Unspecified Respiratory Problem	1	1
Headache	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Fort Defiance Industries, LLC	II	Oct-16-2021
2	Scican Ltd.	II	Aug-03-2023
3	Skytron, Div. The KMW Group, Inc	II	Jun-13-2019
4	Steris Corporation	II	Dec-05-2019
5	Steris Corporation	II	Nov-29-2019
6	Steris Corporation	II	Feb-13-2019