TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Reviews
Manufacturer	Decision
CUSTOM ULTRASONICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDIVATORS, INC.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
WASSENBURG MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Reprocessing Problem	1027	1027
Break	926	931
Connection Problem	323	323
Crack	249	249
Detachment of Device or Device Component	182	182
Improper or Incorrect Procedure or Method	124	124
Failure to Clean Adequately	121	121
Leak/Splash	110	110
Microbial Contamination of Device	94	94
Mechanical Problem	77	77
Use of Device Problem	69	69
Residue After Decontamination	61	61
Contamination	56	56
Failure to Disinfect	55	55
Component Missing	47	47
Disconnection	45	45
Fluid/Blood Leak	40	44
Adverse Event Without Identified Device or Use Problem	40	40
Device Handling Problem	38	38
Degraded	36	36
Fracture	32	32
Material Integrity Problem	28	28
Filling Problem	28	28
Loose or Intermittent Connection	27	27
Insufficient Information	26	26
Output Problem	22	22
Device Contamination with Chemical or Other Material	22	22
Misassembly During Maintenance/Repair	20	20
Defective Device	18	18
Smoking	17	17
Contamination /Decontamination Problem	16	16
Infusion or Flow Problem	16	16
Incomplete or Inadequate Connection	16	16
Restricted Flow rate	16	16
Communication or Transmission Problem	15	15
No Apparent Adverse Event	15	15
Defective Component	15	15
Filtration Problem	14	14
Material Split, Cut or Torn	12	12
Fumes or Vapors	12	12
Device Alarm System	12	12
Obstruction of Flow	12	12
Electrical /Electronic Property Problem	10	10
No Flow	9	9
Particulates	9	9
Insufficient Flow or Under Infusion	8	8
Backflow	8	8
Display or Visual Feedback Problem	8	13
Material Separation	7	7
Mechanical Jam	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3318	3328
No Patient Involvement	292	292
No Consequences Or Impact To Patient	151	151
No Known Impact Or Consequence To Patient	40	40
Insufficient Information	39	42
Burn(s)	30	30
Headache	24	24
Unspecified Infection	16	16
Chemical Exposure	13	13
Pain	12	12
Fever	8	8
Urinary Tract Infection	5	5
Eye Pain	5	5
Urinary Frequency	5	5
Dizziness	5	5
Aspiration/Inhalation	5	5
Dyspnea	5	5
Chills	5	5
Viral Infection	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Subclinical Infection	4	4
Sore Throat	4	4
Sexually Transmitted Infection	4	4
Eye Burn	4	4
Skin Discoloration	4	4
Burning Sensation	4	4
Foreign Body In Patient	4	4
Caustic/Chemical Burns	3	3
Discomfort	3	3
Vomiting	3	3
Abrasion	3	3
Skin Inflammation/ Irritation	3	3
Erythema	2	2
Hepatitis	2	2
Unspecified Eye / Vision Problem	2	2
Asthma	2	2
Inflammation	2	2
No Information	2	2
Unspecified Respiratory Problem	2	2
Drug Resistant Bacterial Infection	2	2
Bruise/Contusion	2	2
Aspiration Pneumonitis	2	2
Injury	1	1
Gastritis	1	1
Laceration(s)	1	1
Cough	1	1
Sepsis	1	1
Nausea	1	1
Hypersensitivity/Allergic reaction	1	1
Arrhythmia	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
10	Steris Corporation	III	Nov-16-2020