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	38	38
Infusion or Flow Problem	32	32
Failure to Deliver	31	31
Mechanical Problem	29	29
Failure to Infuse	26	26
Adverse Event Without Identified Device or Use Problem	14	14
Obstruction of Flow	10	10
Break	9	9
Defective Device	8	8
Failure to Fire	5	5
Failure to Discharge	5	5
Material Twisted/Bent	4	4
Ejection Problem	3	3
Failure to Eject	3	3
Activation, Positioning or Separation Problem	3	3
Detachment of Device or Device Component	3	3
Fluid/Blood Leak	3	3
Difficult to Flush	3	3
Retraction Problem	3	3
Insufficient Flow or Under Infusion	3	3
Failure to Align	2	2
Failure to Advance	2	2
Fracture	2	2
Filling Problem	2	2
Failure to Prime	2	2
Material Puncture/Hole	2	2
Physical Resistance/Sticking	2	2
Mechanical Jam	2	2
Mechanics Altered	1	1
Partial Blockage	1	1
Activation Problem	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
Difficult to Remove	1	1
Off-Label Use	1	1
Nonstandard Device	1	1
No Device Output	1	1
Unsealed Device Packaging	1	1
Complete Blockage	1	1
Contamination	1	1
Difficult to Insert	1	1
Dent in Material	1	1
Deformation Due to Compressive Stress	1	1
Contamination /Decontamination Problem	1	1
Defective Component	1	1
Shipping Damage or Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Dull, Blunt	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	181	181
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