TPLC - Total Product Life Cycle

• Device: sterilizer, ethylene-oxide gas
• Product Code: FLF
• Regulation Number: 880.6860
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	1
ANDERSEN STERILIZERS, INC.
	SUBSTANTIALLY EQUIVALENT	3
TSO3 INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	6	6
2015	3	3
2016	3	3
2017	3	3
2019	2	2
2021	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Displays Incorrect Message	5	5
Device Operates Differently Than Expected	2	2
Device Sensing Problem	2	2
Gas/Air Leak	2	2
Overheating of Device	2	2
Failure to Sense	2	2
Temperature Problem	2	2
No Apparent Adverse Event	2	2
Electrical /Electronic Property Problem	2	2
Leak/Splash	2	2
Appropriate Term/Code Not Available	2	2
Device Emits Odor	1	1
Fluid/Blood Leak	1	1
Device Alarm System	1	1
Break	1	1
Use of Incorrect Control/Treatment Settings	1	1
Failure to Cycle	1	1
Insufficient Information	1	1
Improper Chemical Reaction	1	1
Adverse Event Without Identified Device or Use Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Headache	9	9
Chemical Exposure	6	6
No Known Impact Or Consequence To Patient	5	5
Dizziness	3	3
No Consequences Or Impact To Patient	2	2
Itching Sensation	2	2
Respiratory Distress	1	1
Vomiting	1	1
Burning Sensation	1	1
Irritation	1	1
Burn(s)	1	1
Dyspnea	1	1
Sore Throat	1	1
Not Applicable	1	1
Eye Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Company - Health Care Business	II	Apr-24-2016
2	3M Company - Health Care Business	II	Apr-02-2014
3	3M Company - Health Care Business	II	Oct-09-2012
4	Advanced Sterilization Products	II	Dec-22-2014
5	Advanced Sterilization Products	II	Jan-14-2014
6	Advanced Sterilization Products	II	Jun-15-2009