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	32	32
Mechanical Problem	29	29
Failure to Infuse	26	26
Adverse Event Without Identified Device or Use Problem	14	14
Obstruction of Flow	11	11
Break	9	9
Defective Device	8	8
Failure to Discharge	7	7
Complete Blockage	6	6
Failure to Fire	5	5
Material Twisted/Bent	4	4
Failure to Eject	4	4
Ejection Problem	3	3
Insufficient Flow or Under Infusion	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
Material Puncture/Hole	2	2
Unsealed Device Packaging	2	2
Failure to Prime	2	2
Fracture	2	2
Filling Problem	2	2
Failure to Align	2	2
Failure to Advance	2	2
Physical Resistance/Sticking	2	2
Mechanical Jam	2	2
Mechanics Altered	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
Activation Problem	1	1
Partial Blockage	1	1
Dent in Material	1	1
Tear, Rip or Hole in Device Packaging	1	1
Dull, Blunt	1	1
Defective Component	1	1
Deformation Due to Compressive Stress	1	1
Contamination /Decontamination Problem	1	1
Contamination	1	1
Difficult to Insert	1	1
Off-Label Use	1	1
Nonstandard Device	1	1
No Device Output	1	1
Difficult to Remove	1	1
Shipping Damage or Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	190	190
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