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
CHANGZHOU NEW MED MICRO-MEDTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
G-FLEX EUROPE SPRL
	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 CORPORATION
	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
Failure to Deliver	69	69
No Flow	48	48
Infusion or Flow Problem	40	40
Mechanical Problem	29	29
Failure to Infuse	21	21
Adverse Event Without Identified Device or Use Problem	20	20
Activation Failure	19	19
Physical Resistance/Sticking	12	12
Obstruction of Flow	12	12
Break	10	10
Failure to Discharge	8	8
Defective Device	8	8
Detachment of Device or Device Component	7	7
Failure to Eject	7	7
Complete Blockage	7	7
Difficult to Insert	7	7
Failure to Fire	5	5
Material Twisted/Bent	5	5
Corroded	5	5
Ejection Problem	4	4
Positioning Failure	3	3
Insufficient Flow or Under Infusion	3	3
No Device Output	3	3
Failure to Prime	3	3
Retraction Problem	3	3
Device Fell	2	2
Unsealed Device Packaging	2	2
Defective Component	2	2
Difficult to Advance	2	2
Material Integrity Problem	2	2
Difficult to Flush	2	2
Filling Problem	2	2
Failure to Advance	2	2
Mechanical Jam	2	2
Failure to Align	2	2
Restricted Flow rate	2	2
Difficult or Delayed Activation	2	2
Fracture	2	2
Activation Problem	2	2
Device Contaminated During Manufacture or Shipping	2	2
Activation, Positioning or Separation Problem	2	2
Deformation Due to Compressive Stress	1	1
Material Too Soft/Flexible	1	1
Nonstandard Device	1	1
Device Reprocessing Problem	1	1
Fluid/Blood Leak	1	1
Dull, Blunt	1	1
Tear, Rip or Hole in Device Packaging	1	1
Partial Blockage	1	1
Material Deformation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	320	321
Hemorrhage/Bleeding	12	12
Perforation	4	4
Insufficient Information	4	4
Abdominal Pain	3	3
Fever	3	3
Foreign Body In Patient	3	3
Unspecified Infection	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Gastrointestinal Hemorrhage	2	2
Bowel Perforation	2	2
Pain	2	2
Cough	2	2
Pneumothorax	1	1
Nausea	1	1
Perforation of Esophagus	1	1
Pulmonary Emphysema	1	1
Peritonitis	1	1
Pleural Effusion	1	1
Laceration(s)	1	1
Shock	1	1
Stenosis	1	1
Unspecified Tissue Injury	1	1
Loss of consciousness	1	1
Airway Obstruction	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