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	997	997
Break	810	810
Connection Problem	313	313
Detachment of Device or Device Component	182	182
Crack	154	154
Improper or Incorrect Procedure or Method	131	131
Failure to Clean Adequately	129	129
Leak/Splash	110	110
Microbial Contamination of Device	88	88
Residue After Decontamination	68	68
Contamination	60	60
Failure to Disinfect	49	49
Use of Device Problem	46	46
Mechanical Problem	46	46
Disconnection	44	44
Component Missing	42	42
Filling Problem	40	40
Degraded	34	34
Fracture	30	30
Device Handling Problem	29	29
Material Integrity Problem	27	27
Insufficient Device Problem Information	27	27
Fluid/Blood Leak	26	26
Loose or Intermittent Connection	23	23
Output Problem	21	21
Infusion or Flow Problem	19	19
Misassembly During Maintenance/Repair	18	18
Adverse Event Without Identified Device or Use Problem	18	18
Device Contamination with Chemical or Other Material	17	17
Communication or Transmission Problem	16	16
Incomplete or Inadequate Connection	16	16
Smoking	15	15
Restricted Flow rate	13	13
Contamination /Decontamination Problem	12	12
Defective Component	11	11
No Apparent Adverse Event	11	11
Material Split, Cut or Torn	11	11
Obstruction of Flow	11	11
Filtration Problem	10	10
Particulates	9	9
Fumes or Vapors	9	9
No Flow	9	9
Insufficient Flow or Under Infusion	9	9
Backflow	8	8
Material Separation	7	7
Separation Problem	7	7
Mechanical Jam	7	7
Electrical /Electronic Property Problem	6	6
Defective Device	6	6
Pressure Problem	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3396	3406
No Patient Involvement	55	55
Insufficient Information	40	43
Burn(s)	30	30
No Consequences Or Impact To Patient	26	26
Unspecified Infection	13	13
Pain	12	12
Chemical Exposure	10	10
Headache	10	10
Eye Irritation	8	8
Urinary Tract Infection	8	8
Fever	6	6
Chills	5	5
Dyspnea	5	5
Eye Pain	5	5
Viral Infection	5	5
Aspiration/Inhalation	5	5
Urinary Frequency / Polyuria	5	5
Skin Discoloration	4	4
Subclinical Infection	4	4
Foreign Body In Patient	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Sore Throat	4	4
Sexually Transmitted Infection	4	4
Eye Burn	4	4
Burning Sensation	4	4
Bacterial Infection	3	3
Abrasion	3	3
Discomfort	3	3
Caustic/Chemical Burns	3	3
Skin Inflammation/ Irritation	3	3
Vomiting	3	3
Dizziness	3	3
Drug Resistant Bacterial Infection	2	2
Bruise/Contusion	2	2
Unspecified Respiratory Problem	2	2
Aspiration Pneumonitis	2	2
Unspecified Eye / Vision Problem	2	2
Asthma	2	2
Hepatitis	2	2
Erythema	2	2
Abdominal Pain	1	1
Loss of consciousness	1	1
Laceration(s)	1	1
Hypersensitivity/Allergic reaction	1	1
Inflammation	1	1
Bone Cement Implantation Syndrome	1	1
Gastritis	1	1
Nausea	1	1
Sepsis	1	1

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