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
GA HEALTH COMPANY LIMITED
	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
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
	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	115	115
Detachment of Device or Device Component	89	89
Mechanical Problem	67	67
Retraction Problem	48	48
Material Puncture/Hole	44	44
Material Twisted/Bent	41	41
Leak/Splash	38	38
Burst Container or Vessel	37	37
Physical Resistance/Sticking	31	31
Material Separation	27	27
Adverse Event Without Identified Device or Use Problem	26	27
Use of Device Problem	20	20
Deformation Due to Compressive Stress	15	15
Mechanical Jam	13	13
Device Fell	13	13
Unintended Movement	13	13
Material Split, Cut or Torn	12	12
Defective Device	12	12
Difficult to Advance	10	10
Material Deformation	9	9
Difficult to Remove	9	9
Material Fragmentation	6	6
Positioning Problem	6	6
Material Integrity Problem	6	6
Failure to Advance	6	6
Device Slipped	6	6
Separation Failure	5	5
Fracture	5	5
Defective Component	5	6
Output Problem	5	5
Material Too Rigid or Stiff	5	5
Component Missing	5	6
Inflation Problem	5	5
Failure to Obtain Sample	4	4
Separation Problem	4	4
Material Frayed	4	4
Activation Failure	3	3
Device Dislodged or Dislocated	3	3
Crack	3	3
Loose or Intermittent Connection	3	3
Failure to Fire	3	3
Entrapment of Device	3	3
Positioning Failure	3	3
Unstable	3	3
Material Perforation	3	3
Device Reprocessing Problem	2	2
Firing Problem	2	2
Partial Blockage	2	2
Improper or Incorrect Procedure or Method	2	2
Material Rupture	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	555	555
No Consequences Or Impact To Patient	31	31
Foreign Body In Patient	30	30
Insufficient Information	17	18
Hemorrhage/Bleeding	10	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Pneumothorax	3	3
No Known Impact Or Consequence To Patient	3	3
Cough	3	3
Hypoxia	3	4
Unspecified Infection	2	2
No Code Available	2	2
Needle Stick/Puncture	2	2
Chest Pain	2	2
Unspecified Tissue Injury	2	2
Device Embedded In Tissue or Plaque	2	2
Sleep Dysfunction	1	1
Bronchial Hemorrhage	1	1
Gastrointestinal Hemorrhage	1	1
Hemoptysis	1	1
Perforation	1	1
Cardiac Arrest	1	1
Fever	1	1
No Patient Involvement	1	1
Scar Tissue	1	1
Abscess	1	2
Pneumonia	1	1
Perforation of Vessels	1	2
Unspecified Respiratory Problem	1	1
Respiratory Failure	1	1
Low Oxygen Saturation	1	1
Low Blood Pressure/ Hypotension	1	1
Decreased Respiratory Rate	1	1
Airway Obstruction	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