TPLC - Total Product Life Cycle

• Device: sterilizer, steam
• Product Code: FLE
• Regulation Number: 880.6880
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ALTERNATIVE PIONEERING RESEARCH AND DEVELOPMENT
	SUBSTANTIALLY EQUIVALENT	2
ASTELL SCIENTIFIC LIMITED
	SUBSTANTIALLY EQUIVALENT	1
BELIMED AG
	SUBSTANTIALLY EQUIVALENT	2
BELIMED SAUTER AG
	SUBSTANTIALLY EQUIVALENT	2
BELIMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
CEFLA S.C.
	SUBSTANTIALLY EQUIVALENT	2
CONSOLIDATED MACHINE CORP.
	SUBSTANTIALLY EQUIVALENT	1
ENBIO GROUP AG
	SUBSTANTIALLY EQUIVALENT	2
FORT DEFIANCE INDUSTRIES LLC
	SUBSTANTIALLY EQUIVALENT	1
FORT DEFIANCE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
GETINGE SOURCING LLC
	SUBSTANTIALLY EQUIVALENT	3
GETINGE SOURCING, LLC
	SUBSTANTIALLY EQUIVALENT	1
MAQUET GMBH
	SUBSTANTIALLY EQUIVALENT	3
MIDMARK CORP.
	SUBSTANTIALLY EQUIVALENT	1
MIDMARK CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
MILTON E PEDRAZZI D.D.S., INC.
	SUBSTANTIALLY EQUIVALENT	1
PRIMUS STERILIZER COMPANY, LLC
	SUBSTANTIALLY EQUIVALENT	2
PRIMUS STERILIZER COMPANY, LLC.
	SUBSTANTIALLY EQUIVALENT	2
REVOLUTIONARY SCIENCE
	SUBSTANTIALLY EQUIVALENT	1
SAKURA SEIKI CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
SAUTER AG
	SUBSTANTIALLY EQUIVALENT	2
SCICAN LTD.
	SUBSTANTIALLY EQUIVALENT	6
SHINVA MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STEELCO S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
STERIS
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	14
STURDY INDUSTRIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
TUTTNAUER CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
TUTTNAUER LTD.
	SUBSTANTIALLY EQUIVALENT	4
TUTTNAUER U.S.A CO, LTD
	SUBSTANTIALLY EQUIVALENT	1
TUTTNAUER USA CO. LTD.
	SUBSTANTIALLY EQUIVALENT	2
W&H STERILIZATION S.R.L.
	SUBSTANTIALLY EQUIVALENT	4

MDR Year	MDR Reports	MDR Events
2014	113	113
2015	68	68
2016	76	76
2017	63	63
2018	90	90
2019	91	91
2020	87	87
2021	81	81
2022	70	70
2023	66	66
2024	37	37

Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	184	184
Fluid/Blood Leak	148	148
Adverse Event Without Identified Device or Use Problem	62	62
Device Fell	59	59
Device Operates Differently Than Expected	37	37
Device Tipped Over	29	29
Component Falling	28	28
Insufficient Information	27	27
Detachment of Device or Device Component	23	23
Use of Device Problem	21	21
Noise, Audible	14	14
Failure To Adhere Or Bond	12	12
Unstable	12	12
Smoking	11	11
Unintended Movement	9	9
Improper or Incorrect Procedure or Method	9	9
Device Displays Incorrect Message	9	9
Pressure Problem	9	9
Gas/Air Leak	9	9
Mechanical Problem	8	8
Sparking	8	8
Problem with Software Installation	8	8
Appropriate Term/Code Not Available	8	8
Detachment Of Device Component	7	7
Device Handling Problem	7	7
Moisture or Humidity Problem	7	7
Sharp Edges	6	6
Labelling, Instructions for Use or Training Problem	6	6
Device Emits Odor	6	6
Temperature Problem	6	6
Circuit Failure	5	5
Device Dislodged or Dislocated	5	5
Device Alarm System	5	5
Defective Component	5	5
Loose or Intermittent Connection	5	5
Fire	5	5
Break	5	5
Failure to Align	4	4
Contamination	4	4
Fumes or Vapors	4	4
Protective Measures Problem	4	4
Device Reprocessing Problem	4	4
Unintended System Motion	4	4
Overheating of Device	4	4
Flaked	4	4
Positioning Problem	4	4
Device Contamination with Chemical or Other Material	4	4
Collapse	3	3
Defective Device	3	3
Melted	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	315	315
No Clinical Signs, Symptoms or Conditions	181	181
No Consequences Or Impact To Patient	76	76
Injury	66	66
Burn(s)	41	41
Insufficient Information	31	31
Burn, Thermal	24	24
No Information	21	21
Pain	20	20
Fall	16	16
Laceration(s)	8	8
No Code Available	8	8
No Patient Involvement	6	6
Superficial (First Degree) Burn	6	6
Bone Fracture(s)	3	3
Partial thickness (Second Degree) Burn	3	3
Headache	3	3
Bruise/Contusion	3	3
Abrasion	2	2
Unspecified Infection	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Patient Problem/Medical Problem	2	2
Unspecified Tissue Injury	2	2
Skin Tears	2	2
Inflammation	1	1
Sprain	1	1
Unspecified Ear or Labyrinth Problem	1	1
Respiratory Distress	1	1
Nausea	1	1
Neck Pain	1	1
Burning Sensation	1	1
Complaint, Ill-Defined	1	1
Swelling	1	1
Apnea	1	1
Discomfort	1	1
Ecchymosis	1	1
Hyperextension	1	1
Missing Value Reason	1	1
Muscle/Tendon Damage	1	1
Tachycardia	1	1
Swelling/ Edema	1	1
Unspecified Respiratory Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Fort Defiance Industries, LLC	II	Oct-16-2021
2	Fort Defiance Industries, LLC	II	Jul-10-2018
3	Midmark Corportation	II	Jan-11-2012
4	Scican Ltd.	II	Aug-03-2023
5	Skytron, Div. The KMW Group, Inc	II	Jun-13-2019
6	Steris Corporation	II	Dec-05-2019
7	Steris Corporation	II	Nov-29-2019
8	Steris Corporation	II	Feb-13-2019
9	Steris Corporation	III	Nov-04-2015
10	Steris Corporation	II	Apr-30-2015
11	Steris Corporation	II	Dec-11-2013
12	Steris Corporation	II	Mar-06-2013
13	Steris Corporation	II	May-11-2012