TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
CONSOLIDATED MACHINE CORP.
	SUBSTANTIALLY EQUIVALENT	1
ENBIO GROUP AG
	SUBSTANTIALLY EQUIVALENT	3
FORT DEFIANCE INDUSTRIES, LLC
	SUBSTANTIALLY EQUIVALENT	2
GUANGZHOU AJAX MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LUCAS LIFECARE
	SUBSTANTIALLY EQUIVALENT	1
MAQUET GMBH
	SUBSTANTIALLY EQUIVALENT	2
MAQUET GMBH (A GETINGE GROUP COMPANY)
	SUBSTANTIALLY EQUIVALENT	1
MIDMARK CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NINGBO ICAN MACHINES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PRIMUS STERILIZER COMPANY, LLC
	SUBSTANTIALLY EQUIVALENT	2
SCICAN , LTD.
	SUBSTANTIALLY EQUIVALENT	2
SHINVA MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STEELCO S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
STERIS
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
STURDY INDUSTRIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TUTTNAUER , LTD.
	SUBSTANTIALLY EQUIVALENT	3
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	129	129
Detachment of Device or Device Component	33	33
Device Tipped Over	29	30
Use of Device Problem	23	23
Device Fell	20	20
Insufficient Information	15	15
Fluid/Blood Leak	12	12
Adverse Event Without Identified Device or Use Problem	12	12
Mechanical Problem	10	10
Failure to Align	9	9
Problem with Software Installation	8	8
Pressure Problem	7	7
Labelling, Instructions for Use or Training Problem	6	6
No Apparent Adverse Event	5	5
Sharp Edges	5	5
Unintended Movement	5	5
Device Handling Problem	4	4
Unintended System Motion	4	4
Smoking	4	4
Fire	4	4
Defective Device	3	3
Loose or Intermittent Connection	3	3
Improper or Incorrect Procedure or Method	3	3
Device Dislodged or Dislocated	3	3
Product Quality Problem	3	3
Positioning Problem	2	2
Material Puncture/Hole	2	2
Protective Measures Problem	2	2
Sparking	2	2
Unstable	2	2
Material Separation	2	2
Temperature Problem	2	2
Noise, Audible	2	2
Flaked	1	1
Electrical /Electronic Property Problem	1	1
Display or Visual Feedback Problem	1	1
Difficult to Open or Close	1	1
Overheating of Device	1	1
Connection Problem	1	1
Deformation Due to Compressive Stress	1	1
Nonstandard Device	1	1
Failure to Cycle	1	1
Device Reprocessing Problem	1	1
Mechanical Jam	1	1
Electrical Shorting	1	1
Misassembly During Maintenance/Repair	1	1
Structural Problem	1	1
Particulates	1	1
Thermal Decomposition of Device	1	1
Device Difficult to Maintain	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	221	222
Burn(s)	37	37
Insufficient Information	32	38
Pain	22	22
Laceration(s)	9	9
Bruise/Contusion	7	7
Fall	5	5
No Consequences Or Impact To Patient	5	5
Superficial (First Degree) Burn	4	4
Muscle/Tendon Damage	4	4
Bone Fracture(s)	3	3
Abrasion	3	3
Partial thickness (Second Degree) Burn	3	3
Unspecified Infection	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Unspecified Tissue Injury	2	2
Skin Tears	2	2
Dizziness	1	1
Inflammation	1	1
Unspecified Ear or Labyrinth Problem	1	1
Concussion	1	1
Discomfort	1	1
Ecchymosis	1	1
Hyperextension	1	1
Eye Infections	1	1
Swelling/ Edema	1	1
Unspecified Respiratory Problem	1	1
Headache	1	1
Tinnitus	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Fort Defiance Industries, LLC	II	Oct-16-2021
2	Scican Ltd.	II	Aug-03-2023