TPLC - Total Product Life Cycle

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Device	endoscopic injection needle, gastroenterology-urology
Regulation Description	Endoscope and accessories.
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
LABORIE MEDICAL TECHNOLOGIES CORP.
	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
PROMISEMED HANGZHOU MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
STERIS
	SUBSTANTIALLY EQUIVALENT	1
VEOL MEDICAL TECHNOLOGIES PVT LTD.
	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	55	55
Failure to Deliver	49	49
Infusion or Flow Problem	42	42
Mechanical Problem	29	29
Failure to Infuse	26	26
Adverse Event Without Identified Device or Use Problem	15	15
Physical Resistance/Sticking	12	12
Obstruction of Flow	12	12
Break	9	9
Failure to Discharge	8	8
Defective Device	8	8
Failure to Eject	7	7
Complete Blockage	7	7
Difficult to Insert	6	6
Failure to Fire	5	5
Activation Failure	5	5
Material Twisted/Bent	4	4
Ejection Problem	4	4
Defective Component	3	3
Detachment of Device or Device Component	3	3
Fluid/Blood Leak	3	3
No Device Output	3	3
Insufficient Flow or Under Infusion	3	3
Retraction Problem	3	3
Activation, Positioning or Separation Problem	3	3
Failure to Prime	3	3
Unsealed Device Packaging	2	2
Device Fell	2	2
Failure to Advance	2	2
Fracture	2	2
Material Puncture/Hole	2	2
Difficult to Flush	2	2
Filling Problem	2	2
Mechanical Jam	2	2
Failure to Align	2	2
Nonstandard Device	1	1
Device Reprocessing Problem	1	1
Material Too Soft/Flexible	1	1
Deformation Due to Compressive Stress	1	1
Tear, Rip or Hole in Device Packaging	1	1
Dull, Blunt	1	1
Partial Blockage	1	1
Mechanics Altered	1	1
Blocked Connection	1	1
Improper Flow or Infusion	1	1
Dent in Material	1	1
Positioning Failure	1	1
Shipping Damage or Problem	1	1
Contamination /Decontamination Problem	1	1
Difficult to Remove	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	273	273
No Consequences Or Impact To Patient	19	19
Hemorrhage/Bleeding	11	11
Perforation	4	4
Foreign Body In Patient	3	3
Insufficient Information	3	3
Abdominal Pain	2	2
Gastrointestinal Hemorrhage	2	2
Fever	2	2
Cough	2	2
Nausea	1	1
Bowel Perforation	1	1
Peritonitis	1	1
No Patient Involvement	1	1
Laceration(s)	1	1
Pain	1	1
Shock	1	1
Stenosis	1	1
Unspecified Tissue Injury	1	1
Embolism	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	Nov-15-2024
4	Hobbs Medical, Inc.	II	Oct-07-2022
5	Karl Storz Endoscopy	II	Dec-18-2023
6	Labories Medical Technologies	II	Apr-28-2023