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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
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BYRNE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
CARBON MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND LTD
  SUBSTANTIALLY EQUIVALENT 1
ENDOCHOICE, INC.
  SUBSTANTIALLY EQUIVALENT 2
FINEMEDIX 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, LTD.
  SUBSTANTIALLY EQUIVALENT 1
LINA MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
STERIS
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES ENDOSCOPY GROUP, INC
  SUBSTANTIALLY EQUIVALENT 1
URO-1, INC.
  SUBSTANTIALLY EQUIVALENT 1
UROPLASTY, INC.
  SUBSTANTIALLY EQUIVALENT 2
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL INC.
  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
2014 9 9
2015 4 4
2016 18 18
2017 27 27
2018 9 9
2019 6 6
2020 25 25
2021 34 34
2022 80 80
2023 60 60
2024 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Break 42 42
Adverse Event Without Identified Device or Use Problem 39 39
No Flow 38 38
Infusion or Flow Problem 32 32
Failure to Deliver 31 31
Mechanical Problem 29 29
Failure to Infuse 26 26
Obstruction of Flow 10 10
Defective Device 8 8
Failure to Fire 5 5
Failure to Discharge 5 5
Retraction Problem 4 4
Material Twisted/Bent 4 4
Activation, Positioning or Separation Problem 3 3
Detachment of Device or Device Component 3 3
Ejection Problem 3 3
Failure to Eject 3 3
Insufficient Flow or Under Infusion 3 3
Fluid/Blood Leak 3 3
Difficult to Flush 3 3
Fracture 2 2
Failure to Prime 2 2
Material Separation 2 2
Material Puncture/Hole 2 2
Difficult to Remove 2 2
Filling Problem 2 2
Dull, Blunt 2 2
Physical Resistance/Sticking 2 2
Device Operates Differently Than Expected 2 2
Mechanical Jam 2 2
Failure to Align 2 2
Failure to Advance 2 2
Insufficient Information 2 2
Device Handling Problem 1 1
Activation Failure 1 1
Material Too Soft/Flexible 1 1
Dent in Material 1 1
Mechanics Altered 1 1
Device Contamination with Chemical or Other Material 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Activation Problem 1 1
Pumping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Structural Problem 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Shipping Damage or Problem 1 1
Defective Component 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Off-Label Use 1 1
Disconnection 1 1
Nonstandard Device 1 1
No Device Output 1 1
Unsealed Device Packaging 1 1
Peeled/Delaminated 1 1
Difficult To Position 1 1
Difficult to Insert 1 1
Complete Blockage 1 1
Contamination 1 1
Bent 1 1
Partial Blockage 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 181 181
No Consequences Or Impact To Patient 60 60
Hemorrhage/Bleeding 13 13
No Known Impact Or Consequence To Patient 9 9
Perforation 7 7
Urinary Tract Infection 5 5
Injury 5 5
Blood Loss 4 4
Foreign Body In Patient 4 4
Incontinence 4 4
Fever 3 3
Pain 3 3
No Information 3 3
Hematuria 3 3
Insufficient Information 3 3
Cough 2 2
Septic Shock 2 2
Abdominal Pain 2 2
Dyspnea 1 1
Embolism 1 1
Hemostasis 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Nausea 1 1
Shock 1 1
Tissue Damage 1 1
Peritonitis 1 1
Stenosis 1 1
Unspecified Tissue Injury 1 1
No Patient Involvement 1 1
Bowel Perforation 1 1
No Code Available 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 US Endoscopy Group Inc II Oct-19-2016
7 Wilson-Cook Medical Inc. II Jul-27-2019
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