TPLC - Total Product Life Cycle

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Device	accessories, cleaning, for endoscope
Definition	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	FEB
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
ADVANCED STERILIZATION PRODUCTS (ASP)
	SUBSTANTIALLY EQUIVALENT	1
CUSTOM ULTRASONICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDIVATORS INC
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	2
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	895	895
Device Reprocessing Problem	846	846
Connection Problem	315	315
Crack	249	249
Detachment of Device or Device Component	162	162
Leak/Splash	89	89
Failure to Clean Adequately	87	87
Microbial Contamination of Device	80	80
Mechanical Problem	79	79
Use of Device Problem	66	66
Contamination	47	47
Disconnection	43	43
Component Missing	43	43
Adverse Event Without Identified Device or Use Problem	41	41
Fluid/Blood Leak	39	39
Device Handling Problem	39	39
Failure to Disinfect	39	39
Improper or Incorrect Procedure or Method	33	33
Fracture	30	30
Loose or Intermittent Connection	26	26
Device Contamination with Chemical or Other Material	24	24
Material Integrity Problem	24	24
Misassembly During Maintenance/Repair	21	21
Output Problem	20	20
Defective Device	18	18
Insufficient Information	18	18
Fumes or Vapors	17	17
No Apparent Adverse Event	17	17
Restricted Flow rate	16	16
Incomplete or Inadequate Connection	15	15
Degraded	14	14
Contamination /Decontamination Problem	14	14
Defective Component	14	14
Smoking	14	14
Communication or Transmission Problem	13	13
Device Alarm System	12	12
Filling Problem	11	11
Infusion or Flow Problem	11	11
Material Split, Cut or Torn	11	11
Filtration Problem	9	9
Electrical /Electronic Property Problem	9	9
Display or Visual Feedback Problem	8	8
Obstruction of Flow	8	8
Backflow	8	8
Particulates	7	7
Off-Label Use	7	7
No Flow	7	7
Material Separation	7	7
Residue After Decontamination	7	7
Separation Problem	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2823	2823
No Patient Involvement	294	294
No Consequences Or Impact To Patient	153	153
No Known Impact Or Consequence To Patient	77	77
Insufficient Information	34	34
Burn(s)	26	26
Headache	25	25
Chemical Exposure	25	25
Unspecified Infection	14	14
Pain	8	8
Fever	7	7
Dyspnea	6	6
Foreign Body In Patient	6	6
Urinary Tract Infection	5	5
Urinary Frequency	5	5
Viral Infection	5	5
Chills	5	5
Eye Pain	4	4
Sore Throat	4	4
Sexually Transmitted Infection	4	4
Dizziness	4	4
Vomiting	4	4
Eye Burn	4	4
Caustic/Chemical Burns	3	3
Discomfort	3	3
Burning Sensation	3	3
Inflammation	3	3
Skin Inflammation/ Irritation	3	3
No Information	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Skin Discoloration	2	2
Asthma	2	2
Hepatitis	2	2
Erythema	2	2
Unspecified Eye / Vision Problem	2	2
Nausea	2	2
Unspecified Respiratory Problem	2	2
Drug Resistant Bacterial Infection	2	2
Bacterial Infection	2	2
Aspiration Pneumonitis	2	2
Bruise/Contusion	2	2
Irritation	1	1
Injury	1	1
Gastritis	1	1
Abrasion	1	1
Chest Tightness/Pressure	1	1
Itching Sensation	1	1
Aspiration/Inhalation	1	1
Infection, Indirect	1	1
Skin Irritation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Olympus Corporation of the Americas	II	Feb-07-2024
2	Olympus Corporation of the Americas	II	Aug-23-2023
3	Olympus Corporation of the Americas	II	Aug-04-2023
4	Olympus Corporation of the Americas	II	Feb-11-2022
5	Steris Corporation	II	Aug-08-2024
6	Steris Corporation	II	Dec-22-2023
7	Steris Corporation	III	Nov-16-2020