TPLC - Total Product Life Cycle

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Device	bronchoscope accessory
Regulation Description	Bronchoscope (flexible or rigid) 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	KTI
Regulation Number	874.4680
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALTON (SHANGHAI) MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DISA MEDINOTEC
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN TT MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
FINEMEDIX CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FREE FLOW MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
GA HEALTH COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
LEADOPTIK, INC.
	SUBSTANTIALLY EQUIVALENT	1
M/S MERIL LIFE SCIENCES PVT. , LTD.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PRAXIS MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
SERPEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	123	123
Detachment of Device or Device Component	100	100
Mechanical Problem	67	67
Material Puncture/Hole	57	57
Material Twisted/Bent	48	48
Leak/Splash	47	47
Retraction Problem	46	46
Burst Container or Vessel	36	36
Physical Resistance/Sticking	33	33
Adverse Event Without Identified Device or Use Problem	27	28
Material Separation	26	26
Use of Device Problem	22	22
Mechanical Jam	20	20
Material Split, Cut or Torn	17	17
Deformation Due to Compressive Stress	15	15
Material Perforation	15	15
Difficult to Remove	11	11
Fracture	11	11
Difficult to Advance	11	11
Unintended Movement	11	11
Defective Device	10	10
Inflation Problem	10	10
Failure to Advance	9	9
Material Deformation	9	9
Material Fragmentation	8	8
Material Integrity Problem	7	7
Positioning Problem	7	7
Separation Failure	6	6
Material Too Rigid or Stiff	6	6
Device Slipped	6	6
Device Fell	6	6
Defective Component	5	6
Component Missing	5	6
Material Frayed	5	5
Positioning Failure	5	5
Activation Failure	5	5
Output Problem	5	5
Failure to Obtain Sample	4	4
Failure to Fire	4	4
Separation Problem	4	4
Failure to Eject	4	4
Firing Problem	3	3
Difficult to Open or Close	3	3
Device Dislodged or Dislocated	3	3
Crack	3	3
Entrapment of Device	3	3
Loose or Intermittent Connection	3	3
Unstable	3	3
Improper or Incorrect Procedure or Method	2	2
Fitting Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	666	666
Foreign Body In Patient	29	29
Insufficient Information	22	23
Hemorrhage/Bleeding	8	9
No Consequences Or Impact To Patient	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Pneumothorax	3	3
Needle Stick/Puncture	3	3
Cough	3	3
Hypoxia	3	4
Unspecified Infection	2	2
Chest Pain	2	2
Unspecified Tissue Injury	2	2
Sleep Dysfunction	1	1
Bronchial Hemorrhage	1	1
Gastrointestinal Hemorrhage	1	1
Perforation	1	1
Cardiac Arrest	1	1
Fever	1	1
Abscess	1	2
Pneumonia	1	1
Perforation of Vessels	1	2
Unspecified Respiratory Problem	1	1
Airway Obstruction	1	1
Low Blood Pressure/ Hypotension	1	1
Low Oxygen Saturation	1	1
Respiratory Failure	1	1
Decreased Respiratory Rate	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Bryan Medical Inc	II	Jul-17-2023
2	Integra LifeSciences Corp. (NeuroSciences)	II	May-06-2025
3	Olympus Corporation of the Americas	I	Sep-05-2025