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
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	65	65
No Flow	56	56
Infusion or Flow Problem	42	42
Mechanical Problem	29	29
Failure to Infuse	26	26
Adverse Event Without Identified Device or Use Problem	20	20
Activation Failure	18	18
Obstruction of Flow	12	12
Physical Resistance/Sticking	12	12
Break	10	10
Defective Device	8	8
Failure to Discharge	8	8
Complete Blockage	7	7
Failure to Eject	7	7
Difficult to Insert	7	7
Failure to Fire	5	5
Material Twisted/Bent	5	5
Detachment of Device or Device Component	4	4
Ejection Problem	4	4
Activation, Positioning or Separation Problem	4	4
Defective Component	3	3
Fluid/Blood Leak	3	4
Retraction Problem	3	3
Failure to Prime	3	3
Insufficient Flow or Under Infusion	3	3
No Device Output	3	3
Restricted Flow rate	2	2
Filling Problem	2	2
Difficult to Flush	2	2
Material Puncture/Hole	2	3
Device Fell	2	2
Unsealed Device Packaging	2	2
Failure to Advance	2	2
Material Integrity Problem	2	2
Mechanical Jam	2	2
Fracture	2	2
Positioning Failure	2	2
Failure to Align	2	2
Deformation Due to Compressive Stress	1	1
Material Too Soft/Flexible	1	1
Nonstandard Device	1	1
Device Reprocessing Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Partial Blockage	1	1
Material Deformation	1	1
Dull, Blunt	1	1
Mechanics Altered	1	1
Blocked Connection	1	1
Improper Flow or Infusion	1	1
Dent in Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	305	307
No Consequences Or Impact To Patient	19	19
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
Gastrointestinal Hemorrhage	2	2
Bowel Perforation	2	2
Pain	2	2
Cough	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Pneumothorax	1	1
Nausea	1	1
Perforation of Esophagus	1	1
Pulmonary Emphysema	1	1
Peritonitis	1	1
Pleural Effusion	1	1
No Patient Involvement	1	1
Laceration(s)	1	1
Shock	1	1
Stenosis	1	1
Unspecified Tissue Injury	1	1
Embolism	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