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
ACCLARENT, INC.
	SUBSTANTIALLY EQUIVALENT	2
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BRYAN MEDICAL , INC.
	SUBSTANTIALLY EQUIVALENT	1
DISA MEDINOTEC
	SUBSTANTIALLY EQUIVALENT	1
DONGGUAN TT MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
GA HEALTH COMPANY LIMITED
	SUBSTANTIALLY EQUIVALENT	1
INTUIT MEDICAL PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
M/S MERIL LIFE SCIENCES PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDIVATORS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
	SUBSTANTIALLY EQUIVALENT	4
PRAXIS MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
SERPEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPIRATION, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	95	95
Detachment of Device or Device Component	61	61
Mechanical Problem	61	61
Retraction Problem	40	40
Burst Container or Vessel	35	35
Material Puncture/Hole	29	29
Leak/Splash	27	27
Material Separation	25	25
Material Twisted/Bent	24	24
Adverse Event Without Identified Device or Use Problem	23	23
Physical Resistance/Sticking	21	21
Use of Device Problem	19	19
Device Fell	12	12
Mechanical Jam	11	11
Defective Device	10	10
Difficult to Remove	9	9
Difficult to Advance	8	8
Unintended Movement	8	8
Material Split, Cut or Torn	7	7
Deformation Due to Compressive Stress	7	7
Material Deformation	7	7
Deflation Problem	5	5
Device Slipped	5	5
Separation Failure	5	5
Output Problem	5	5
Material Fragmentation	5	5
Inflation Problem	4	4
Component Missing	4	4
Separation Problem	4	4
Failure to Obtain Sample	4	4
Insufficient Information	3	3
Entrapment of Device	3	3
Positioning Failure	3	3
Failure to Advance	3	3
Device Dislodged or Dislocated	3	3
Defective Component	3	3
Failure to Eject	2	2
Loose or Intermittent Connection	2	2
Improper or Incorrect Procedure or Method	2	2
Unstable	2	2
Material Perforation	2	2
Difficult or Delayed Positioning	1	1
Material Too Rigid or Stiff	1	1
Device Handling Problem	1	1
Bent	1	1
Fracture	1	1
Suction Problem	1	1
Device Reprocessing Problem	1	1
Ejection Problem	1	1
Microbial Contamination of Device	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	55	55
Foreign Body In Patient	28	28
No Known Impact Or Consequence To Patient	27	27
Insufficient Information	12	12
Hemorrhage/Bleeding	8	8
No Code Available	5	5
Hypoxia	3	3
Unspecified Infection	2	2
Pneumothorax	2	2
Chest Pain	2	2
Abscess	2	2
Cough	2	2
Unspecified Tissue Injury	2	2
Device Embedded In Tissue or Plaque	2	2
Sleep Dysfunction	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Information	1	1
Hemoptysis	1	1
Foreign body, removal of	1	1
Tooth Fracture	1	1
Cardiac Arrest	1	1
Needle Stick/Puncture	1	1
Fever	1	1
No Patient Involvement	1	1
Scar Tissue	1	1
Pneumonia	1	1
Perforation of Vessels	1	1
Embolism	1	1
Unspecified Respiratory Problem	1	1
Breathing difficulties	1	1
Bacterial Infection	1	1
Airway Obstruction	1	1
Respiratory Failure	1	1
Low Oxygen Saturation	1	1
Low Blood Pressure/ Hypotension	1	1
Decreased Respiratory Rate	1	1