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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
FINEMEDIX CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU AGS MEDTECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
URO-1, INC.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 27 27
2018 9 9
2019 6 6
2020 25 25
2021 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Break 34 34
Infusion or Flow Problem 13 13
No Flow 8 8
Adverse Event Without Identified Device or Use Problem 7 7
Failure to Infuse 7 7
Defective Device 6 6
Failure to Fire 3 3
Insufficient Flow or Under Infusion 3 3
Ejection Problem 3 3
Obstruction of Flow 2 2
Material Puncture/Hole 2 2
Filling Problem 2 2
Fluid Leak 2 2
Activation, Positioning or SeparationProblem 2 2
Failure to Deliver 2 2
Bent 1 1
Dull, Blunt 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Device Contamination with Chemical or Other Material 1 1
Difficult to Flush 1 1
Fracture 1 1
Failure to Prime 1 1
Shipping Damage or Problem 1 1
Defective Component 1 1
Structural Problem 1 1
Insufficient Information 1 1
Device Handling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 48 48
No Clinical Signs, Symptoms or Conditions 35 35
No Known Impact Or Consequence To Patient 7 7
No Information 2 2
Hemorrhage/Bleeding 2 2
Hemostasis 1 1
Nausea 1 1
Embolism 1 1
No Code Available 1 1
Insufficient Information 1 1
Injury 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Wilson-Cook Medical Inc. II Jul-27-2019
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