TPLC - Total Product Life Cycle

• Device: accessories, germicide, cleaning, for endoscopes
• Definition: High level disinfection of reusable, heat-sensitive devices If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
• Product Code: NZA
• Regulation Number: 876.1500
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
STERIS
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	7

MDR Year	MDR Reports	MDR Events
2014	6	6
2015	10	10
2016	21	21
2017	9	9
2018	8	8
2019	2	2
2020	1	1
2021	4	4
2022	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	17	17
Device Emits Odor	14	14
Leak/Splash	13	13
Device Operates Differently Than Expected	7	7
Smoking	5	5
Detachment Of Device Component	4	4
Residue After Decontamination	2	2
Device Displays Incorrect Message	2	2
Patient-Device Incompatibility	1	1
Chemical Problem	1	1
Connection Problem	1	1
Disconnection	1	1
Fire	1	1
Loose or Intermittent Connection	1	1
Improper or Incorrect Procedure or Method	1	1
Difficult to Open or Close	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	42	42
No Consequences Or Impact To Patient	7	7
No Clinical Signs, Symptoms or Conditions	6	6
No Patient Involvement	3	3
Headache	2	2
Irritation	1	1
Fall	1	1
No Information	1	1
Foreign Body In Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Steris Corporation	II	Sep-20-2013