TPLC - Total Product Life Cycle

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Device	endoscopic injection needle, gastroenterology-urology
Definition	inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
Product Code	FBK
Regulation Number	876.1500
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALTON (SHANGHAI) MEDICAL INSTRUMENTS CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
ANREI MEDICAL (HANGZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING ZKSK TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
G-FLEX EUROPE SPRL
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU AGS MEDTECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
INCORE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
LINA MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	1
NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
OLYMPUS MEDICAL SYSTEMS CORP.
	SUBSTANTIALLY EQUIVALENT	1
STERIS
	SUBSTANTIALLY EQUIVALENT	1
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
	SUBSTANTIALLY EQUIVALENT	1
YANGZHOU FARTLEY MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Flow	39	39
Failure to Deliver	38	38
Infusion or Flow Problem	34	34
Mechanical Problem	29	29
Failure to Infuse	26	26
Adverse Event Without Identified Device or Use Problem	14	14
Physical Resistance/Sticking	11	11
Obstruction of Flow	11	11
Break	9	9
Defective Device	8	8
Complete Blockage	7	7
Failure to Discharge	7	7
Failure to Fire	5	5
Failure to Eject	5	5
Material Twisted/Bent	4	4
Failure to Prime	4	4
Fluid/Blood Leak	3	3
Difficult to Flush	3	3
Retraction Problem	3	3
Insufficient Flow or Under Infusion	3	3
Ejection Problem	3	3
Activation, Positioning or Separation Problem	3	3
Detachment of Device or Device Component	3	3
Mechanical Jam	2	2
Defective Component	2	2
Failure to Align	2	2
Failure to Advance	2	2
Fracture	2	2
Difficult to Insert	2	2
Filling Problem	2	2
Material Puncture/Hole	2	2
No Device Output	2	2
Unsealed Device Packaging	2	2
Nonstandard Device	1	1
Difficult to Remove	1	1
Off-Label Use	1	1
Contamination	1	1
Dent in Material	1	1
Deformation Due to Compressive Stress	1	1
Contamination /Decontamination Problem	1	1
Shipping Damage or Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Dull, Blunt	1	1
Mechanics Altered	1	1
Partial Blockage	1	1
Activation Problem	1	1
Difficult to Advance	1	1
Device Contaminated During Manufacture or Shipping	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Pumping Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Insufficient Information	1	1
Activation Failure	1	1
Material Too Soft/Flexible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	213	213
No Consequences Or Impact To Patient	20	20
Hemorrhage/Bleeding	12	12
Perforation	4	4
Insufficient Information	3	3
Fever	2	2
Cough	2	2
Abdominal Pain	2	2
Foreign Body In Patient	2	2
No Known Impact Or Consequence To Patient	2	2
No Information	1	1
No Code Available	1	1
Peritonitis	1	1
Stenosis	1	1
No Patient Involvement	1	1
Bowel Perforation	1	1
Embolism	1	1
Shock	1	1
Laceration(s)	1	1
Nausea	1	1
Pain	1	1
Unspecified Tissue Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Aomori Olympus Co., Ltd.	II	Feb-05-2021
2	Boston Scientific Corporation	II	Nov-11-2022
3	Hobbs Medical, Inc.	II	Oct-07-2022
4	Karl Storz Endoscopy	II	Dec-18-2023
5	Labories Medical Technologies	II	Apr-28-2023
6	Wilson-Cook Medical Inc.	II	Jul-27-2019