TPLC - Total Product Life Cycle

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Device	accessories, cleaning, for endoscope
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
ADVANCED STERILIZATION PRODUCTS (ASP)
	SUBSTANTIALLY EQUIVALENT	1
CUSTOM ULTRASONICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDIVATORS INC
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	2
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Reprocessing Problem	811	811
Break	811	811
Connection Problem	294	294
Crack	246	246
Detachment of Device or Device Component	143	143
Failure to Clean Adequately	78	78
Mechanical Problem	78	78
Leak/Splash	77	77
Microbial Contamination of Device	77	77
Use of Device Problem	63	63
Contamination	47	47
Adverse Event Without Identified Device or Use Problem	41	41
Component Missing	40	40
Failure to Disinfect	39	39
Fluid/Blood Leak	39	39
Device Handling Problem	39	39
Disconnection	35	35
Improper or Incorrect Procedure or Method	31	31
Fracture	30	30
Loose or Intermittent Connection	25	25
Device Contamination with Chemical or Other Material	24	24
Material Integrity Problem	23	23
Misassembly During Maintenance/Repair	21	21
Defective Device	18	18
No Apparent Adverse Event	17	17
Fumes or Vapors	17	17
Output Problem	15	15
Incomplete or Inadequate Connection	15	15
Insufficient Information	15	15
Contamination /Decontamination Problem	14	14
Restricted Flow rate	13	13
Defective Component	13	13
Communication or Transmission Problem	12	12
Degraded	12	12
Device Alarm System	12	12
Infusion or Flow Problem	11	11
Smoking	11	11
Filling Problem	11	11
Material Split, Cut or Torn	11	11
Electrical /Electronic Property Problem	9	9
Display or Visual Feedback Problem	8	8
Filtration Problem	8	8
Obstruction of Flow	8	8
Particulates	7	7
Off-Label Use	7	7
No Flow	7	7
Residue After Decontamination	7	7
Separation Problem	7	7
Material Separation	6	6
Device Difficult to Maintain	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2613	2613
No Patient Involvement	294	294
No Consequences Or Impact To Patient	153	153
No Known Impact Or Consequence To Patient	77	77
Insufficient Information	34	34
Chemical Exposure	25	25
Headache	23	23
Burn(s)	23	23
Unspecified Infection	14	14
Pain	7	7
Fever	7	7
Dyspnea	6	6
Foreign Body In Patient	6	6
Urinary Tract Infection	5	5
Urinary Frequency	5	5
Chills	5	5
Viral Infection	5	5
Eye Pain	4	4
Sore Throat	4	4
Dizziness	4	4
Eye Burn	4	4
Sexually Transmitted Infection	4	4
Vomiting	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
No Information	3	3
Skin Inflammation/ Irritation	3	3
Inflammation	3	3
Caustic/Chemical Burns	3	3
Discomfort	3	3
Aspiration Pneumonitis	2	2
Bruise/Contusion	2	2
Bacterial Infection	2	2
Unspecified Respiratory Problem	2	2
Unspecified Eye / Vision Problem	2	2
Erythema	2	2
Burning Sensation	2	2
Hepatitis	2	2
Asthma	2	2
Nausea	2	2
Drug Resistant Bacterial Infection	2	2
Injury	1	1
Irritation	1	1
Skin Discoloration	1	1
Chest Tightness/Pressure	1	1
Itching Sensation	1	1
Gastritis	1	1
Eye Injury	1	1
Abrasion	1	1
Cough	1	1
Aspiration/Inhalation	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