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
WILSON-COOK MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
WILSON-COOK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	44	44
Break	41	41
Material Twisted/Bent	27	27
Mechanical Problem	17	17
Adverse Event Without Identified Device or Use Problem	16	16
Retraction Problem	14	14
Material Deformation	8	8
Material Separation	6	6
Device Contaminated During Manufacture or Shipping	3	3
Difficult to Advance	3	3
Material Fragmentation	2	2
Activation Problem	2	2
Difficult or Delayed Separation	1	1
Unsealed Device Packaging	1	1
Peeled/Delaminated	1	1
Use of Device Problem	1	1
Defective Device	1	1
Contamination /Decontamination Problem	1	1
Difficult to Open or Close	1	1
Device Dislodged or Dislocated	1	1
Device Contamination with Chemical or Other Material	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	51	51
No Clinical Signs, Symptoms or Conditions	38	38
No Known Impact Or Consequence To Patient	19	19
Foreign Body In Patient	12	12
Insufficient Information	6	6
Pneumothorax	4	4
Bronchial Hemorrhage	3	3
Hemorrhage/Bleeding	3	3
No Code Available	2	2
Pancreatitis	2	2
Perforation	1	1
Cardiac Arrest	1	1
Fever	1	1