TPLC - Total Product Life Cycle

show TPLC since

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	102	102
Fluid/Blood Leak	58	58
Device Fell	55	55
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	17	17
Insufficient Information	13	13
Problem with Software Installation	8	8
Pressure Problem	7	7
Labelling, Instructions for Use or Training Problem	6	6
Device Handling Problem	6	6
Sharp Edges	6	6
Unstable	6	6
Device Alarm System	5	5
Smoking	4	4
Unintended System Motion	4	4
Unintended Movement	4	4
Fire	4	4
Mechanical Problem	4	4
Temperature Problem	4	4
Flaked	4	4
Device Dislodged or Dislocated	4	4
Gas/Air Leak	4	4
Device Slipped	3	3
Loose or Intermittent Connection	3	3
No Apparent Adverse Event	3	3
Product Quality Problem	3	3
Protective Measures Problem	3	3
Failure to Align	3	3
Defective Device	3	3
Noise, Audible	2	2
Improper or Incorrect Procedure or Method	2	2
Moisture or Humidity Problem	2	2
Sparking	2	2
Material Separation	2	2
Material Puncture/Hole	2	2
Overheating of Device	2	2
Positioning Problem	2	2
Difficult to Open or Close	2	2
Therapeutic or Diagnostic Output Failure	2	2
Structural Problem	1	1
Thermal Decomposition of Device	1	1
Material Fragmentation	1	1
Particulates	1	1
Shipping Damage or Problem	1	1
Contamination /Decontamination Problem	1	1
Contamination	1	1
Device Reprocessing Problem	1	1
Failure to Cycle	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	181	181
No Known Impact Or Consequence To Patient	69	69
No Consequences Or Impact To Patient	38	38
Insufficient Information	31	31
Burn(s)	24	24
Injury	18	18
Burn, Thermal	14	14
Pain	14	14
Fall	7	7
Laceration(s)	5	5
Superficial (First Degree) Burn	4	4
No Information	3	3
Bone Fracture(s)	3	3
Bruise/Contusion	3	3
Unspecified Infection	2	2
Patient Problem/Medical Problem	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Code Available	2	2
Abrasion	2	2
Unspecified Tissue Injury	2	2
Skin Tears	2	2
Inflammation	1	1
Unspecified Ear or Labyrinth Problem	1	1
Discomfort	1	1
No Patient Involvement	1	1
Ecchymosis	1	1
Hyperextension	1	1
Muscle/Tendon Damage	1	1
Swelling/ Edema	1	1
Partial thickness (Second Degree) Burn	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