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
CARBON MEDICAL TECHNOLOGIES, INC.
	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
MIRCO-TECH (NANJING) CO., LTD.
	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	72	72
No Flow	50	50
Infusion or Flow Problem	40	40
Mechanical Problem	29	29
Activation Failure	25	25
Adverse Event Without Identified Device or Use Problem	22	22
Failure to Infuse	21	21
Physical Resistance/Sticking	12	12
Obstruction of Flow	12	12
Break	11	11
Material Twisted/Bent	9	9
Detachment of Device or Device Component	9	9
Failure to Discharge	8	8
Defective Device	8	8
Failure to Eject	7	7
Complete Blockage	7	7
Difficult to Insert	7	7
Material Deformation	5	5
Failure to Fire	5	5
Corroded	5	5
Ejection Problem	5	5
Activation Problem	4	4
Positioning Failure	4	4
Failure to Prime	3	3
Leak/Splash	3	3
Activation, Positioning or Separation Problem	3	3
Retraction Problem	3	3
No Device Output	3	3
Mechanical Jam	3	3
Insufficient Flow or Under Infusion	3	3
Tear, Rip or Hole in Device Packaging	2	2
Difficult or Delayed Activation	2	2
Failure to Align	2	2
Fracture	2	2
Failure to Advance	2	2
Material Integrity Problem	2	2
Defective Component	2	2
Unsealed Device Packaging	2	2
Device Fell	2	2
Difficult to Advance	2	2
Material Puncture/Hole	2	2
Difficult to Flush	2	2
Filling Problem	2	2
Restricted Flow rate	2	2
Device Contaminated During Manufacture or Shipping	2	2
Device Reprocessing Problem	1	1
Nonstandard Device	1	1
Material Too Soft/Flexible	1	1
Deformation Due to Compressive Stress	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	349	350
Hemorrhage/Bleeding	12	12
Perforation	5	5
Insufficient Information	5	5
Abdominal Pain	4	4
Gastrointestinal Hemorrhage	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
Bowel Perforation	2	2
Pain	2	2
Cough	2	2
Melena	1	1
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
Hematemesis	1	1
Muscle/Tendon Damage	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