TPLC - Total Product Life Cycle

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Device	endoscopic cytology brush
Definition	To collect cells for cytological evaluation.
Product Code	FDX
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	2
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
UNITED STATES ENDOSCOPY GROUP, INC.
	SUBSTANTIALLY EQUIVALENT	2
WILSON-COOK MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
WILSON-COOK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	137	137
Bent	57	57
Detachment of Device or Device Component	46	46
Detachment Of Device Component	46	46
Material Twisted/Bent	40	40
Adverse Event Without Identified Device or Use Problem	34	34
Mechanical Problem	22	22
Retraction Problem	22	22
Patient-Device Incompatibility	14	14
Material Deformation	10	10
Material Separation	8	8
Insufficient Information	5	5
Device Contamination with Chemical or Other Material	4	4
Difficult to Advance	4	4
Device Contaminated During Manufacture or Shipping	3	3
Use of Device Problem	3	3
Material Fragmentation	3	3
Material Frayed	2	2
Defective Device	2	2
Activation Problem	2	2
Device Dislodged or Dislocated	2	2
Difficult or Delayed Separation	1	1
Contamination /Decontamination Problem	1	1
Difficult to Open or Close	1	1
Device Operates Differently Than Expected	1	1
Material Integrity Problem	1	1
Material Protrusion/Extrusion	1	1
Appropriate Term/Code Not Available	1	1
Device Handling Problem	1	1
Positioning Problem	1	1
Material Rupture	1	1
Component Missing	1	1
Unraveled Material	1	1
Migration or Expulsion of Device	1	1
Unsealed Device Packaging	1	1
Peeled/Delaminated	1	1
Component Falling	1	1
Decrease in Suction	1	1
Fracture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	255	255
No Known Impact Or Consequence To Patient	41	41
No Clinical Signs, Symptoms or Conditions	38	38
Foreign Body In Patient	16	16
Pneumothorax	16	16
Insufficient Information	6	6
No Information	5	5
Death	5	5
Hemorrhage/Bleeding	5	5
Inflammation	3	3
Sepsis	3	3
Bronchial Hemorrhage	3	3
Pancreatitis	2	2
No Code Available	2	2
Device Embedded In Tissue or Plaque	2	2
Hemoptysis	2	2
Blood Loss	2	2
Complaint, Ill-Defined	1	1
Injury	1	1
Perforation	1	1
Unspecified Infection	1	1
Dyspnea	1	1
Fever	1	1
Anemia	1	1
Cardiac Arrest	1	1