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
MAQUET GMBH
	SUBSTANTIALLY EQUIVALENT	2
MIDMARK CORPORATION
	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	109	109
Fluid/Blood Leak	45	45
Device Fell	31	31
Device Tipped Over	27	27
Detachment of Device or Device Component	26	26
Adverse Event Without Identified Device or Use Problem	21	21
Use of Device Problem	18	18
Insufficient Information	13	13
Problem with Software Installation	8	8
Sharp Edges	8	8
Pressure Problem	6	6
Mechanical Problem	6	6
Labelling, Instructions for Use or Training Problem	6	6
Failure to Align	6	6
Temperature Problem	4	4
Fire	4	4
Flaked	4	4
Unintended System Motion	4	4
Unintended Movement	4	4
No Apparent Adverse Event	4	4
Device Handling Problem	4	4
Improper or Incorrect Procedure or Method	3	3
Loose or Intermittent Connection	3	3
Device Dislodged or Dislocated	3	3
Defective Device	3	3
Positioning Problem	3	3
Product Quality Problem	3	3
Noise, Audible	2	2
Difficult to Open or Close	2	2
Protective Measures Problem	2	2
Material Separation	2	2
Gas/Air Leak	2	2
Smoking	2	2
Material Puncture/Hole	2	2
Sparking	2	2
Unstable	2	2
Thermal Decomposition of Device	1	1
Particulates	1	1
Structural Problem	1	1
Device Difficult to Maintain	1	1
Misassembly During Maintenance/Repair	1	1
Positioning Failure	1	1
Shipping Damage or Problem	1	1
Material Fragmentation	1	1
Contamination /Decontamination Problem	1	1
Contamination	1	1
Electrical Shorting	1	1
Device Contamination with Chemical or Other Material	1	1
Unintended Electrical Shock	1	1
Device Reprocessing Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	207	207
Insufficient Information	34	34
Burn(s)	30	30
No Known Impact Or Consequence To Patient	23	23
No Consequences Or Impact To Patient	23	23
Pain	16	16
Burn, Thermal	6	6
Injury	6	6
Laceration(s)	6	6
Bruise/Contusion	6	6
Superficial (First Degree) Burn	4	4
Muscle/Tendon Damage	4	4
Bone Fracture(s)	3	3
Fall	3	3
Partial thickness (Second Degree) Burn	3	3
Unspecified Infection	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	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
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