TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
CONSOLIDATED MACHINE CORP.
	SUBSTANTIALLY EQUIVALENT	1
ENBIO GROUP AG
	SUBSTANTIALLY EQUIVALENT	2
FORT DEFIANCE INDUSTRIES, LLC
	SUBSTANTIALLY EQUIVALENT	2
GUANGZHOU AJAX MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MAQUET GMBH
	SUBSTANTIALLY EQUIVALENT	2
MIDMARK CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NINGBO ICAN MACHINES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PRIMUS STERILIZER COMPANY, LLC
	SUBSTANTIALLY EQUIVALENT	2
SCICAN , LTD.
	SUBSTANTIALLY EQUIVALENT	3
SHINVA MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STEELCO S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
STERIS
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
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
Fluid/Blood Leak	45	45
Device Fell	34	34
Detachment of Device or Device Component	32	32
Device Tipped Over	29	30
Adverse Event Without Identified Device or Use Problem	22	22
Use of Device Problem	21	21
Insufficient Information	15	15
Sharp Edges	9	9
Mechanical Problem	9	9
Problem with Software Installation	8	8
Failure to Align	7	7
Labelling, Instructions for Use or Training Problem	6	6
Pressure Problem	6	6
No Apparent Adverse Event	5	5
Fire	5	5
Unintended Movement	4	4
Defective Device	4	4
Flaked	4	4
Unintended System Motion	4	4
Temperature Problem	4	4
Device Handling Problem	4	4
Device Dislodged or Dislocated	4	4
Loose or Intermittent Connection	3	3
Positioning Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Product Quality Problem	3	3
Material Puncture/Hole	2	2
Smoking	2	2
Difficult to Open or Close	2	2
Gas/Air Leak	2	2
Sparking	2	2
Material Separation	2	2
Unstable	2	2
Protective Measures Problem	2	2
Noise, Audible	2	2
Display or Visual Feedback Problem	1	1
Corroded	1	1
Overheating of Device	1	1
Deformation Due to Compressive Stress	1	1
Mechanical Jam	1	1
Connection Problem	1	1
Nonstandard Device	1	1
Failure to Cycle	1	1
Device Reprocessing Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Electrical Shorting	1	1
Misassembly During Maintenance/Repair	1	1
Structural Problem	1	1
Particulates	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	233	234
Burn(s)	39	39
Insufficient Information	34	40
No Known Impact Or Consequence To Patient	23	23
No Consequences Or Impact To Patient	23	23
Pain	18	18
Laceration(s)	8	8
Bruise/Contusion	7	7
Burn, Thermal	6	6
Injury	6	6
Fall	5	5
Superficial (First Degree) Burn	4	4
Muscle/Tendon Damage	4	4
Bone Fracture(s)	3	3
Partial thickness (Second Degree) Burn	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Unspecified Infection	2	2
Abrasion	2	2
Unspecified Tissue Injury	2	2
Skin Tears	2	2
Patient Problem/Medical Problem	1	1
No Code Available	1	1
Dizziness	1	1
Inflammation	1	1
Unspecified Ear or Labyrinth Problem	1	1
Discomfort	1	1
Concussion	1	1
Ecchymosis	1	1
Hyperextension	1	1
Eye Infections	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