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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscopic injection needle, gastroenterology-urology
Definition inserted through endoscope for injection of a solution, gas, or implantable materials into gi or gu tissue.
Product CodeFBK
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
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
LINA MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1
NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
STERIS
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
  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

MDR Year MDR Reports MDR Events
2019 6 6
2020 25 25
2021 34 34
2022 80 80
2023 60 60
2024 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
No Flow 38 38
Failure to Deliver 33 33
Infusion or Flow Problem 32 32
Mechanical Problem 29 29
Failure to Infuse 26 26
Adverse Event Without Identified Device or Use Problem 14 14
Obstruction of Flow 11 11
Break 9 9
Defective Device 8 8
Failure to Discharge 7 7
Complete Blockage 6 6
Failure to Fire 5 5
Physical Resistance/Sticking 5 5
Failure to Eject 4 4
Material Twisted/Bent 4 4
Ejection Problem 3 3
Activation, Positioning or Separation Problem 3 3
Detachment of Device or Device Component 3 3
Retraction Problem 3 3
Insufficient Flow or Under Infusion 3 3
Fluid/Blood Leak 3 3
Difficult to Flush 3 3
Fracture 2 2
Filling Problem 2 2
Material Puncture/Hole 2 2
No Device Output 2 2
Unsealed Device Packaging 2 2
Failure to Prime 2 2
Failure to Align 2 2
Failure to Advance 2 2
Mechanical Jam 2 2
Mechanics Altered 1 1
Partial Blockage 1 1
Activation Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Pumping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Activation Failure 1 1
Material Too Soft/Flexible 1 1
Dent in Material 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Defective Component 1 1
Shipping Damage or Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Off-Label Use 1 1
Difficult to Remove 1 1
Nonstandard Device 1 1
Contamination 1 1
Difficult to Insert 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 195 195
No Consequences Or Impact To Patient 20 20
Hemorrhage/Bleeding 12 12
Perforation 4 4
Insufficient Information 3 3
Fever 2 2
Cough 2 2
Abdominal Pain 2 2
Foreign Body In Patient 2 2
No Known Impact Or Consequence To Patient 2 2
No Information 1 1
No Code Available 1 1
Peritonitis 1 1
Stenosis 1 1
No Patient Involvement 1 1
Bowel Perforation 1 1
Embolism 1 1
Shock 1 1
Laceration(s) 1 1
Nausea 1 1
Pain 1 1
Unspecified Tissue Injury 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 Oct-07-2022
4 Karl Storz Endoscopy II Dec-18-2023
5 Labories Medical Technologies II Apr-28-2023
6 Wilson-Cook Medical Inc. II Jul-27-2019
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