TPLC - Total Product Life Cycle

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Device	accessories, cleaning, for endoscope
Regulation Description	Endoscope and accessories.
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Reprocessing Problem	969	969
Break	809	814
Connection Problem	312	312
Detachment of Device or Device Component	180	180
Crack	165	165
Improper or Incorrect Procedure or Method	120	120
Failure to Clean Adequately	115	115
Leak/Splash	109	109
Microbial Contamination of Device	86	86
Residue After Decontamination	55	55
Contamination	52	52
Failure to Disinfect	50	50
Use of Device Problem	47	47
Mechanical Problem	47	47
Disconnection	44	44
Component Missing	41	41
Degraded	32	32
Fluid/Blood Leak	30	34
Fracture	30	30
Device Handling Problem	29	29
Material Integrity Problem	27	27
Insufficient Information	26	26
Adverse Event Without Identified Device or Use Problem	24	24
Loose or Intermittent Connection	24	24
Output Problem	22	22
Filling Problem	20	20
Misassembly During Maintenance/Repair	18	18
Device Contamination with Chemical or Other Material	18	18
Smoking	16	16
Incomplete or Inadequate Connection	16	16
Communication or Transmission Problem	15	15
Infusion or Flow Problem	14	14
Restricted Flow rate	13	13
Contamination /Decontamination Problem	12	12
Defective Component	12	12
Fumes or Vapors	11	11
Obstruction of Flow	11	11
No Apparent Adverse Event	11	11
Material Split, Cut or Torn	11	11
Filtration Problem	9	9
Particulates	9	9
No Flow	9	9
Insufficient Flow or Under Infusion	8	8
Backflow	8	8
Mechanical Jam	7	7
Material Separation	7	7
Electrical /Electronic Property Problem	7	7
Display or Visual Feedback Problem	7	12
Separation Problem	7	7
Defective Device	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3281	3291
No Patient Involvement	55	55
Insufficient Information	38	41
Burn(s)	30	30
No Consequences Or Impact To Patient	26	26
Pain	11	11
Unspecified Infection	10	10
Headache	10	10
Chemical Exposure	9	9
Urinary Tract Infection	5	5
Urinary Frequency	5	5
Eye Pain	5	5
Dyspnea	5	5
Viral Infection	5	5
Chills	5	5
Fever	5	5
Aspiration/Inhalation	5	5
Skin Discoloration	4	4
Eye Burn	4	4
Foreign Body In Patient	4	4
Burning Sensation	4	4
Subclinical Infection	4	4
Sexually Transmitted Infection	4	4
Sore Throat	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Dizziness	3	3
Discomfort	3	3
Skin Inflammation/ Irritation	3	3
Vomiting	3	3
Caustic/Chemical Burns	3	3
Asthma	2	2
Abrasion	2	2
Hepatitis	2	2
Erythema	2	2
Unspecified Eye / Vision Problem	2	2
Unspecified Respiratory Problem	2	2
Drug Resistant Bacterial Infection	2	2
Aspiration Pneumonitis	2	2
Bruise/Contusion	2	2
Gastritis	1	1
Inflammation	1	1
Nausea	1	1
Laceration(s)	1	1
Cough	1	1
Hypersensitivity/Allergic reaction	1	1
Arrhythmia	1	1
Abdominal Pain	1	1
Loss of consciousness	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aizu Olympus Co., Ltd.	II	Dec-02-2025
2	Olympus Corporation of the Americas	II	Mar-20-2026
3	Olympus Corporation of the Americas	II	Feb-07-2024
4	Olympus Corporation of the Americas	II	Aug-23-2023
5	Olympus Corporation of the Americas	II	Aug-04-2023
6	Olympus Corporation of the Americas	II	Feb-11-2022
7	Steris Corporation	II	Aug-08-2024
8	Steris Corporation	II	Dec-22-2023