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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device biopsy needle
Product CodeFCG
Regulation Number 876.1075
Device Class 2


Premarket Reviews
ManufacturerDecision
APRIOMED AB
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU DETAIN MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND LTD.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
FINEMEDIX CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
SUZHOU LEAPMED HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
USHARE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K191472  Biopsy Needle
WILSON-COOK MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 273 273
2018 282 282
2019 229 229
2020 240 240
2021 289 289
2022 147 147

Device Problems MDRs with this Device Problem Events in those MDRs
Break 417 417
Fracture 167 167
Material Twisted/Bent 148 148
Adverse Event Without Identified Device or Use Problem 106 106
Retraction Problem 93 93
Occlusion Within Device 82 82
Bent 80 80
Off-Label Use 71 71
Improper or Incorrect Procedure or Method 69 69
Kinked 65 65
Difficult to Remove 43 43
Physical Resistance/Sticking 43 43
Material Deformation 40 40
Detachment of Device or Device Component 36 36
Material Separation 33 33
Material Perforation 31 31
Mechanical Problem 18 18
Insufficient Information 18 18
Activation, Positioning or SeparationProblem 14 14
Difficult to Advance 14 14
Device Contamination with Chemical or Other Material 13 13
Use of Device Problem 13 13
Failure to Advance 12 12
Detachment Of Device Component 12 12
Defective Device 10 10
Device Fell 10 10
No Apparent Adverse Event 9 9
Device Damaged Prior to Use 8 8
Device Markings/Labelling Problem 7 7
Material Fragmentation 7 7
Material Puncture/Hole 7 7
Unsealed Device Packaging 6 6
Device Slipped 6 6
Appropriate Term/Code Not Available 6 6
Output Problem 6 6
Device-Device Incompatibility 5 5
Loose or Intermittent Connection 5 5
Difficult to Insert 4 4
Positioning Failure 4 4
Device Operates Differently Than Expected 4 4
Device Damaged by Another Device 4 4
Structural Problem 4 4
Difficult to Open or Close 4 4
Mechanical Jam 4 4
Tear, Rip or Hole in Device Packaging 4 4
Positioning Problem 4 4
Physical Property Issue 3 3
Material Split, Cut or Torn 3 3
Defective Component 3 3
Material Integrity Problem 3 3
Device Dislodged or Dislocated 3 3
Loss of or Failure to Bond 3 3
Component Falling 3 3
Contamination 3 3
Entrapment of Device 3 3
Leak/Splash 3 3
Shipping Damage or Problem 3 3
Material Too Rigid or Stiff 3 3
Peeled/Delaminated 3 3
Disconnection 2 2
Device Contaminated During Manufacture or Shipping 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Misfire 2 2
Failure to Obtain Sample 2 2
Failure to Eject 2 2
Activation Problem 2 2
Separation Problem 2 2
Packaging Problem 2 2
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Unclear Information 1 1
Activation Failure 1 1
Failure to Disconnect 1 1
Difficult or Delayed Activation 1 1
Failure to Fire 1 1
Wrinkled 1 1
Delivery System Failure 1 1
Out-Of-Box Failure 1 1
Device Issue 1 1
Dull, Blunt 1 1
Obstruction of Flow 1 1
Material Protrusion/Extrusion 1 1
Expiration Date Error 1 1
Device Packaging Compromised 1 1
Accessory Incompatible 1 1
Flaked 1 1
Fluid Leak 1 1
Failure to Prime 1 1
Migration or Expulsion of Device 1 1
Nonstandard Device 1 1
Sticking 1 1
Stretched 1 1
Device Inoperable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 420 420
No Consequences Or Impact To Patient 408 408
No Clinical Signs, Symptoms or Conditions 300 300
Foreign Body In Patient 188 188
Hemorrhage/Bleeding 39 39
No Patient Involvement 33 33
No Code Available 25 25
Device Embedded In Tissue or Plaque 23 23
Insufficient Information 16 16
Gastrointestinal Hemorrhage 12 12
Blood Loss 11 11
Injury 11 11
Abdominal Pain 11 11
Unspecified Infection 10 10
Inflammation 10 10
Needle Stick/Puncture 10 10
Pancreatitis 10 10
Pain 9 9
Pneumothorax 9 9
Hematoma 9 9
Fever 8 8
Abscess 8 8
Perforation 7 7
Peritonitis 6 6
Death 6 6
No Information 6 6
Radiation Exposure, Unintended 4 4
Unspecified Hepatic or Biliary Problem 4 4
Sepsis 4 4
Low Blood Pressure/ Hypotension 3 3
Cough 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Unspecified Gastrointestinal Problem 3 3
Cancer 2 2
Not Applicable 2 2
Confusion/ Disorientation 2 2
Hypoxia 2 2
Pneumonia 2 2
Cardiac Arrest 2 2
Cyst(s) 2 2
Exposure to Body Fluids 2 2
Hemoptysis 2 2
Hemostasis 2 2
Hemothorax 1 1
Hepatitis 1 1
Fistula 1 1
Bradycardia 1 1
Biliary Cirrhosis 1 1
Pulmonary Emphysema 1 1
Extravasation 1 1
Liver Damage/Dysfunction 1 1
Muscle Weakness 1 1
Internal Organ Perforation 1 1
Strangulation 1 1
Perforation of Vessels 1 1
Vomiting 1 1
Mediastinal Shift 1 1
Discomfort 1 1
Respiratory Distress 1 1
Ascites 1 1
Sedation 1 1
Bronchospasm 1 1
Vessel Or Plaque, Device Embedded In 1 1
Fibrosis 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Bard Peripheral Vascular Inc II Oct-02-2018
3 Covidien Llc II Aug-05-2020
4 Medtronic II Feb-28-2017
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