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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
Regulation Description Endoscope and accessories.
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
ANREI MEDICAL (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CARBON MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ENDOCHOICE, INC.
  SUBSTANTIALLY EQUIVALENT 1
FINEMEDIX CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU AGS MEDTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
URO-1, INC.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 18 18
2017 27 27
2018 9 9
2019 6 6
2020 25 25
2021 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Break 38 38
Adverse Event Without Identified Device or Use Problem 17 17
Infusion or Flow Problem 10 10
No Flow 8 8
Failure to Infuse 7 7
Insufficient Information 2 2
Material Puncture/Hole 2 2
Activation, Positioning or SeparationProblem 2 2
Fluid Leak 2 2
Material Separation 2 2
Shipping Damage or Problem 1 1
Component Missing 1 1
Failure to Deliver 1 1
Structural Problem 1 1
Difficult to Flush 1 1
Fracture 1 1
Failure to Prime 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Retraction Problem 1 1
Device Handling Problem 1 1
Material Twisted/Bent 1 1
Bent 1 1
Dull, Blunt 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Disconnection 1 1
Insufficient Flow or Under Infusion 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 55 55
No Clinical Signs, Symptoms or Conditions 16 16
No Known Impact Or Consequence To Patient 9 9
Injury 5 5
Blood Loss 4 4
No Information 3 3
Hemorrhage/Bleeding 2 2
Urinary Tract Infection 2 2
Foreign Body In Patient 2 2
Hematuria 2 2
Insufficient Information 1 1
Dyspnea 1 1
Embolism 1 1
Hemostasis 1 1
Nausea 1 1
No Code Available 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 US Endoscopy Group Inc II Oct-19-2016
3 Wilson-Cook Medical Inc. II Jul-27-2019
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