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
NANOSONICS LIMITED
	GRANTED	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
Break	915	915
Device Reprocessing Problem	914	914
Connection Problem	322	322
Crack	249	249
Detachment of Device or Device Component	168	168
Failure to Clean Adequately	106	106
Leak/Splash	97	97
Microbial Contamination of Device	86	86
Mechanical Problem	75	75
Improper or Incorrect Procedure or Method	67	67
Use of Device Problem	65	65
Disconnection	45	45
Contamination	45	45
Failure to Disinfect	45	45
Component Missing	43	43
Fluid/Blood Leak	38	38
Device Handling Problem	38	38
Adverse Event Without Identified Device or Use Problem	37	37
Fracture	32	32
Loose or Intermittent Connection	27	27
Material Integrity Problem	25	25
Insufficient Information	22	22
Device Contamination with Chemical or Other Material	21	21
Output Problem	21	21
Misassembly During Maintenance/Repair	20	20
Residue After Decontamination	19	19
Defective Device	18	18
Incomplete or Inadequate Connection	16	16
Restricted Flow rate	16	16
Smoking	16	16
Degraded	16	16
Defective Component	15	15
Filling Problem	14	14
No Apparent Adverse Event	14	14
Communication or Transmission Problem	13	13
Infusion or Flow Problem	13	13
Contamination /Decontamination Problem	13	13
Device Alarm System	12	12
Fumes or Vapors	12	12
Material Split, Cut or Torn	11	11
Electrical /Electronic Property Problem	10	10
Filtration Problem	9	9
Particulates	9	9
Display or Visual Feedback Problem	8	8
No Flow	8	8
Obstruction of Flow	8	8
Backflow	8	8
Mechanical Jam	7	7
Separation Problem	7	7
Insufficient Flow or Under Infusion	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3021	3021
No Patient Involvement	292	292
No Consequences Or Impact To Patient	151	151
No Known Impact Or Consequence To Patient	40	40
Insufficient Information	35	35
Burn(s)	27	27
Headache	23	23
Unspecified Infection	13	13
Chemical Exposure	11	11
Pain	10	10
Fever	7	7
Urinary Tract Infection	5	5
Urinary Frequency	5	5
Dyspnea	5	5
Viral Infection	5	5
Chills	5	5
Eye Pain	4	4
Sexually Transmitted Infection	4	4
Burning Sensation	4	4
Foreign Body In Patient	4	4
Eye Burn	4	4
Dizziness	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Skin Discoloration	3	3
Aspiration/Inhalation	3	3
Discomfort	3	3
Skin Inflammation/ Irritation	3	3
Vomiting	3	3
Caustic/Chemical Burns	3	3
Sore Throat	3	3
Asthma	2	2
Hepatitis	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
Aspiration Pneumonitis	2	2
Bruise/Contusion	2	2
Injury	1	1
Gastritis	1	1
Abrasion	1	1
Cough	1	1
Nausea	1	1
Hypersensitivity/Allergic reaction	1	1
Bacterial Infection	1	1
Arrhythmia	1	1
Abdominal Pain	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