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 SURGICAL TECHNOLOGIES AMERICA
	SUBSTANTIALLY EQUIVALENT	1
PRAXIS MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
SERPEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	87	87
Detachment of Device or Device Component	72	72
Mechanical Problem	64	64
Retraction Problem	42	42
Burst Container or Vessel	31	31
Material Puncture/Hole	29	29
Material Twisted/Bent	25	25
Physical Resistance/Sticking	25	25
Material Separation	25	25
Leak/Splash	23	23
Adverse Event Without Identified Device or Use Problem	22	22
Use of Device Problem	18	18
Mechanical Jam	12	12
Device Fell	12	12
Unintended Movement	10	10
Defective Device	10	10
Deformation Due to Compressive Stress	9	9
Difficult to Remove	8	8
Material Split, Cut or Torn	7	7
Difficult to Advance	7	7
Material Fragmentation	6	6
Component Missing	5	5
Output Problem	5	5
Material Deformation	5	5
Separation Failure	5	5
Inflation Problem	4	4
Positioning Problem	4	4
Failure to Obtain Sample	4	4
Defective Component	4	4
Device Slipped	4	4
Material Integrity Problem	3	3
Failure to Advance	3	3
Device Dislodged or Dislocated	3	3
Entrapment of Device	3	3
Separation Problem	3	3
Positioning Failure	3	3
Firing Problem	2	2
Device Damaged by Another Device	2	2
Material Perforation	2	2
Loose or Intermittent Connection	2	2
Improper or Incorrect Procedure or Method	2	2
Failure to Eject	2	2
Unstable	2	2
Material Too Rigid or Stiff	1	1
Difficult to Insert	1	1
Ejection Problem	1	1
Mechanics Altered	1	1
Patient Device Interaction Problem	1	1
Difficult or Delayed Positioning	1	1
Scratched Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	416	416
No Consequences Or Impact To Patient	31	31
Foreign Body In Patient	28	28
Insufficient Information	13	13
Hemorrhage/Bleeding	9	9
No Known Impact Or Consequence To Patient	3	3
Cough	3	3
Hypoxia	3	3
Pneumothorax	2	2
No Code Available	2	2
Chest Pain	2	2
Unspecified Tissue Injury	2	2
Device Embedded In Tissue or Plaque	2	2
Unspecified Infection	1	1
Sleep Dysfunction	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hemoptysis	1	1
Perforation	1	1
Cardiac Arrest	1	1
Fever	1	1
Needle Stick/Puncture	1	1
No Patient Involvement	1	1
Scar Tissue	1	1
Abscess	1	1
Pneumonia	1	1
Perforation of Vessels	1	1
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

Recalls
Manufacturer		Recall Class	Date Posted
1	Bryan Medical Inc	II	Jul-17-2023