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	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	124	124
Detachment of Device or Device Component	31	31
Device Tipped Over	28	28
Use of Device Problem	23	23
Insufficient Device Problem Information	15	15
Device Fell	14	14
Mechanical Problem	10	10
Unintended Movement	8	8
Problem with Software Installation	8	8
Failure to Align	8	8
Pressure Problem	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Labelling, Instructions for Use or Training Problem	6	6
Sharp Edges	5	5
No Apparent Adverse Event	5	5
Device Handling Problem	4	4
Smoking	4	4
Fire	4	4
Unintended System Motion	3	3
Improper or Incorrect Procedure or Method	3	3
Device Dislodged or Dislocated	3	3
Material Puncture/Hole	2	2
Material Separation	2	2
Temperature Problem	2	2
Positioning Problem	2	2
Sparking	2	2
Unintended Electrical Shock	1	1
Material Split, Cut or Torn	1	1
Noise, Audible	1	1
Device Difficult to Maintain	1	1
Mechanical Jam	1	1
Electrical Shorting	1	1
Difficult to Open or Close	1	1
Connection Problem	1	1
Contamination /Decontamination Problem	1	1
Structural Problem	1	1
Defective Component	1	1
Electrical /Electronic Property Problem	1	1
Display or Visual Feedback Problem	1	1
Positioning Failure	1	1
Failure to Cycle	1	1
Contamination	1	1
Device Reprocessing Problem	1	1
Circuit Failure	1	1
Break	1	1
Device Slipped	1	1
Device Damaged Prior to Receipt by User	1	1
Particulates	1	1
Overheating of Device	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	228	229
Burn(s)	38	38
Insufficient Information	32	38
Pain	22	22
Laceration(s)	9	9
Bruise/Contusion	7	7
No Consequences Or Impact To Patient	5	5
Fall	5	5
Superficial (First Degree) Burn	4	4
Muscle/Tendon Damage	4	4
Partial thickness (Second Degree) Burn	3	3
Bone Fracture(s)	3	3
Abrasion	3	3
Skin Tears	2	2
Unspecified Tissue Injury	2	2
Unspecified Infection	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Limb Pain	1	1
Eye Infections	1	1
Inflammation	1	1
Ecchymosis	1	1
Concussion	1	1
Headache	1	1
Ear Pain	1	1
Tinnitus	1	1
Unspecified Respiratory Problem	1	1
Hyperextension	1	1
Unspecified Ear or Labyrinth Problem	1	1
Swelling/ Edema	1	1
Dizziness	1	1
Discomfort	1	1

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