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	47	47
Infusion or Flow Problem	41	41
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
Failure to Discharge	8	8
Break	8	8
Defective Device	8	8
Failure to Eject	7	7
Complete Blockage	7	7
Failure to Fire	5	5
Material Twisted/Bent	4	4
Ejection Problem	4	4
No Device Output	3	3
Activation, Positioning or Separation Problem	3	3
Fluid/Blood Leak	3	3
Detachment of Device or Device Component	3	3
Retraction Problem	3	3
Failure to Prime	3	3
Defective Component	3	3
Insufficient Flow or Under Infusion	3	3
Difficult to Insert	3	3
Mechanical Jam	2	2
Failure to Advance	2	2
Failure to Align	2	2
Unsealed Device Packaging	2	2
Device Fell	2	2
Material Puncture/Hole	2	2
Difficult to Flush	2	2
Filling Problem	2	2
Contamination /Decontamination Problem	1	1
Shipping Damage or Problem	1	1
Difficult to Remove	1	1
Contamination	1	1
Dent in Material	1	1
Improper Flow or Infusion	1	1
Therapeutic or Diagnostic Output Failure	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Blocked Connection	1	1
Mechanics Altered	1	1
Partial Blockage	1	1
Insufficient Information	1	1
Difficult to Advance	1	1
Tear, Rip or Hole in Device Packaging	1	1
Activation Failure	1	1
Fracture	1	1
Pumping Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	262	262
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
Fever	2	2
Cough	2	2
Nausea	1	1
Gastrointestinal Hemorrhage	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