TPLC - Total Product Life Cycle

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Device	indicator, physical/chemical sterilization process
Product Code	JOJ
Regulation Number	880.2800
Device Class	2

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	13
ANDERSEN STERILIZERS, INC.
	SUBSTANTIALLY EQUIVALENT	2
ANDERSEN STERILIZERS,INC.
	SUBSTANTIALLY EQUIVALENT	1
CROSSTEX INTERNATIONAL, INC. (A CANTEL MEDICAL COMPANY)
	SUBSTANTIALLY EQUIVALENT	1
INTERTAPE POLYMER INC.
	SUBSTANTIALLY EQUIVALENT	1
KEM MEDICAL PRODUCTS CORP.
	SUBSTANTIALLY EQUIVALENT	1
PROPPER MANUFACTURING CO., INC.
	SUBSTANTIALLY EQUIVALENT	3
SERIM RESEARCH CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
STERILUCENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPARATION
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	9
STERIS CORPORATIONS
	SUBSTANTIALLY EQUIVALENT	1
STERITEC PRODUCTS MFG CO INC
	SUBSTANTIALLY EQUIVALENT	1
TERRAGENE SA
	SUBSTANTIALLY EQUIVALENT	1
U&U MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Chemical Problem	31	31
Device Operates Differently Than Expected	29	29
Unexpected Color	19	19
Material Discolored	6	6
Shelf Life Exceeded	6	6
Problem with Sterilization	4	4
Product Quality Problem	4	4
Output Problem	4	4
Contamination /Decontamination Problem	3	3
Detachment of Device or Device Component	3	3
Improper or Incorrect Procedure or Method	3	3
Delivered as Unsterile Product	3	3
Expiration Date Error	2	2
Defective Device	2	2
Use of Device Problem	2	2
Incorrect, Inadequate or Imprecise Resultor Readings	2	2
Packaging Problem	2	2
Appropriate Term/Code Not Available	2	2
Device Handling Problem	2	2
Non Reproducible Results	1	1
Missing Information	1	1
Therapeutic or Diagnostic Output Failure	1	1
No Apparent Adverse Event	1	1
Device Disinfection Or Sterilization Issue	1	1
Activation, Positioning or SeparationProblem	1	1
Device Damaged by Another Device	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Optical Discoloration	1	1
Material Rupture	1	1
Material Separation	1	1
Device Expiration Issue	1	1
Nonstandard Device	1	1
Loss of or Failure to Bond	1	1
Burst Container or Vessel	1	1
Device Reprocessing Problem	1	1
Device Slipped	1	1
Device Damaged Prior to Use	1	1
Device Rinsing Issue	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	33	33
No Patient Involvement	24	24
No Known Impact Or Consequence To Patient	22	22
Insufficient Information	13	13
No Consequences Or Impact To Patient	11	11
Partial thickness (Second Degree) Burn	1	1
Not Applicable	1	1
Foreign Body In Patient	1	1
Hemorrhage/Bleeding	1	1
Skin Discoloration	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Resource Optimization & Innovation LLC	II	Jul-24-2020
2	Young Dental Mfg Co I LLC	II	Feb-02-2022