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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
WILSON-COOK MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K171596  ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echot ...
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
Physical Resistance/Sticking 43 43
Difficult to Remove 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
Use of Device Problem 13 13
Device Contamination with Chemical or Other Material 13 13
Failure to Advance 12 12
Detachment Of Device Component 12 12
Device Fell 10 10
Defective Device 10 10
No Apparent Adverse Event 9 9
Device Damaged Prior to Use 8 8
Device Markings/Labelling Problem 7 7
Material Puncture/Hole 7 7
Material Fragmentation 7 7
Unsealed Device Packaging 6 6
Device Slipped 6 6
Output Problem 6 6
Appropriate Term/Code Not Available 6 6
Loose or Intermittent Connection 5 5
Device-Device Incompatibility 5 5
Tear, Rip or Hole in Device Packaging 4 4
Positioning Failure 4 4
Device Operates Differently Than Expected 4 4
Device Damaged by Another Device 4 4
Mechanical Jam 4 4
Difficult to Insert 4 4
Positioning Problem 4 4
Difficult to Open or Close 4 4
Structural Problem 4 4
Loss of or Failure to Bond 3 3
Shipping Damage or Problem 3 3
Device Dislodged or Dislocated 3 3
Physical Property Issue 3 3
Material Split, Cut or Torn 3 3
Component Falling 3 3
Entrapment of Device 3 3
Material Too Rigid or Stiff 3 3
Defective Component 3 3
Contamination 3 3
Leak/Splash 3 3
Peeled/Delaminated 3 3
Material Integrity Problem 3 3
Failure to Obtain Sample 2 2
Device Contaminated During Manufacture or Shipping 2 2
Disconnection 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Misfire 2 2
Failure to Eject 2 2
Activation Problem 2 2
Separation Problem 2 2
Packaging Problem 2 2
Therapeutic or Diagnostic Output Failure 1 1
Nonstandard Device 1 1
Fluid Leak 1 1
Delivery System Failure 1 1
Stretched 1 1
Obstruction of Flow 1 1
Failure to Disconnect 1 1
Difficult or Delayed Activation 1 1
Activation Failure 1 1
Flaked 1 1
Dull, Blunt 1 1
Failure to Fire 1 1
Unintended Movement 1 1
Sticking 1 1
Device Inoperable 1 1
Accessory Incompatible 1 1
Failure to Prime 1 1
Migration or Expulsion of Device 1 1
Device Packaging Compromised 1 1
Material Protrusion/Extrusion 1 1
Out-Of-Box Failure 1 1
Device Issue 1 1
Expiration Date Error 1 1
Wrinkled 1 1
Protective Measures Problem 1 1
Unclear Information 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
Abdominal Pain 11 11
Blood Loss 11 11
Injury 11 11
Needle Stick/Puncture 10 10
Unspecified Infection 10 10
Inflammation 10 10
Pancreatitis 10 10
Hematoma 9 9
Pain 9 9
Pneumothorax 9 9
Abscess 8 8
Fever 8 8
Perforation 7 7
Peritonitis 6 6
Death 6 6
No Information 6 6
Unspecified Hepatic or Biliary Problem 4 4
Sepsis 4 4
Radiation Exposure, Unintended 4 4
Cough 3 3
Unspecified Gastrointestinal Problem 3 3
Low Blood Pressure/ Hypotension 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Cyst(s) 2 2
Confusion/ Disorientation 2 2
Not Applicable 2 2
Hemoptysis 2 2
Hypoxia 2 2
Cancer 2 2
Pneumonia 2 2
Exposure to Body Fluids 2 2
Cardiac Arrest 2 2
Hemostasis 2 2
Hemothorax 1 1
Fistula 1 1
Respiratory Distress 1 1
Vomiting 1 1
Discomfort 1 1
Ascites 1 1
Bronchospasm 1 1
Fibrosis 1 1
Perforation of Vessels 1 1
Vessel Or Plaque, Device Embedded In 1 1
Hepatitis 1 1
Muscle Weakness 1 1
Extravasation 1 1
Liver Damage/Dysfunction 1 1
Internal Organ Perforation 1 1
Biliary Cirrhosis 1 1
Bradycardia 1 1
Patient Problem/Medical Problem 1 1
Pulmonary Emphysema 1 1
Sedation 1 1
Strangulation 1 1
Mediastinal Shift 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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