TPLC - Total Product Life Cycle

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Device	bronchoscope accessory
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
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 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	89	89
Detachment of Device or Device Component	61	61
Mechanical Problem	61	61
Retraction Problem	39	39
Burst Container or Vessel	30	30
Material Puncture/Hole	27	27
Material Twisted/Bent	24	24
Leak/Splash	23	23
Material Separation	23	23
Physical Resistance/Sticking	21	21
Adverse Event Without Identified Device or Use Problem	19	19
Use of Device Problem	19	19
Device Fell	12	12
Mechanical Jam	11	11
Defective Device	9	9
Difficult to Advance	8	8
Unintended Movement	8	8
Difficult to Remove	8	8
Deformation Due to Compressive Stress	7	7
Material Split, Cut or Torn	7	7
Material Deformation	5	5
Output Problem	5	5
Separation Failure	5	5
Material Fragmentation	5	5
Inflation Problem	4	4
Component Missing	4	4
Failure to Obtain Sample	4	4
Separation Problem	4	4
Device Slipped	4	4
Defective Component	3	3
Positioning Failure	3	3
Entrapment of Device	3	3
Failure to Advance	3	3
Device Dislodged or Dislocated	3	3
Material Perforation	2	2
Failure to Eject	2	2
Loose or Intermittent Connection	2	2
Improper or Incorrect Procedure or Method	2	2
Unstable	2	2
Material Integrity Problem	1	1
Positioning Problem	1	1
Deflation Problem	1	1
Scratched Material	1	1
Ejection Problem	1	1
Difficult to Insert	1	1
Material Too Rigid or Stiff	1	1
Fail-Safe Did Not Operate	1	1
Collapse	1	1
Device Stenosis	1	1
Mechanics Altered	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	365	365
No Consequences Or Impact To Patient	42	42
Foreign Body In Patient	27	27
No Known Impact Or Consequence To Patient	17	17
Insufficient Information	12	12
Hemorrhage/Bleeding	8	8
Hypoxia	3	3
No Code Available	2	2
Chest Pain	2	2
Cough	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
Pneumothorax	1	1
Hemoptysis	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
Low Blood Pressure/ Hypotension	1	1
Low Oxygen Saturation	1	1
Respiratory Failure	1	1
Decreased Respiratory Rate	1	1