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

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	954	954
Break	918	923
Connection Problem	322	322
Crack	249	249
Detachment of Device or Device Component	168	168
Failure to Clean Adequately	111	111
Leak/Splash	102	102
Improper or Incorrect Procedure or Method	93	93
Microbial Contamination of Device	90	90
Mechanical Problem	77	77
Use of Device Problem	67	67
Failure to Disinfect	52	52
Contamination	50	50
Disconnection	45	45
Component Missing	43	43
Adverse Event Without Identified Device or Use Problem	39	39
Fluid/Blood Leak	38	42
Device Handling Problem	38	38
Residue After Decontamination	35	35
Fracture	32	32
Loose or Intermittent Connection	27	27
Insufficient Information	25	25
Material Integrity Problem	25	25
Degraded	24	24
Output Problem	22	22
Device Contamination with Chemical or Other Material	22	22
Misassembly During Maintenance/Repair	20	20
Defective Device	18	18
Smoking	16	16
Incomplete or Inadequate Connection	16	16
Restricted Flow rate	16	16
Defective Component	15	15
No Apparent Adverse Event	15	15
Contamination /Decontamination Problem	15	15
Filling Problem	15	15
Communication or Transmission Problem	13	13
Infusion or Flow Problem	13	13
Device Alarm System	12	12
Fumes or Vapors	12	12
Material Split, Cut or Torn	11	11
Filtration Problem	11	11
Obstruction of Flow	10	10
Electrical /Electronic Property Problem	10	10
Particulates	9	9
Backflow	8	8
Display or Visual Feedback Problem	8	13
No Flow	8	8
Insufficient Flow or Under Infusion	7	7
Separation Problem	7	7
Material Separation	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3115	3125
No Patient Involvement	292	292
No Consequences Or Impact To Patient	151	151
No Known Impact Or Consequence To Patient	40	40
Insufficient Information	38	41
Burn(s)	28	28
Headache	23	23
Unspecified Infection	13	13
Chemical Exposure	12	12
Pain	11	11
Fever	7	7
Urinary Tract Infection	5	5
Eye Pain	5	5
Urinary Frequency	5	5
Dyspnea	5	5
Viral Infection	5	5
Chills	5	5
Sexually Transmitted Infection	4	4
Foreign Body In Patient	4	4
Burning Sensation	4	4
Eye Burn	4	4
Aspiration/Inhalation	4	4
Dizziness	4	4
Subclinical Infection	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Skin Discoloration	3	3
Vomiting	3	3
Discomfort	3	3
Skin Inflammation/ Irritation	3	3
Caustic/Chemical Burns	3	3
Sore Throat	3	3
Hepatitis	2	2
Asthma	2	2
Inflammation	2	2
Erythema	2	2
Unspecified Eye / Vision Problem	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
Gastritis	1	1
Abrasion	1	1
Injury	1	1
Nausea	1	1
Hypersensitivity/Allergic reaction	1	1
Cough	1	1
Arrhythmia	1	1
Abdominal Pain	1	1
Bacterial Infection	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