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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
BIBBINSTRUMENTS AB
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND LTD.
  SUBSTANTIALLY EQUIVALENT 2
FINEMEDIX CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIMACA MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU LEAPMED HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
USHARE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 229 229
2020 240 240
2021 289 289
2022 304 304
2023 430 430
2024 106 106

Device Problems MDRs with this Device Problem Events in those MDRs
Break 378 378
Fracture 273 273
Material Twisted/Bent 207 207
Adverse Event Without Identified Device or Use Problem 157 157
Improper or Incorrect Procedure or Method 145 145
Off-Label Use 116 116
Retraction Problem 90 90
Physical Resistance/Sticking 84 84
Detachment of Device or Device Component 70 70
Difficult to Remove 41 41
Material Perforation 36 36
Material Separation 34 34
Use of Device Problem 32 32
Mechanical Problem 29 29
Difficult to Advance 24 24
Device Contamination with Chemical or Other Material 21 21
Device Damaged Prior to Use 20 20
Insufficient Information 20 20
Material Deformation 16 16
Device-Device Incompatibility 16 16
Failure to Advance 14 14
Dent in Material 13 13
Device Fell 12 12
Material Puncture/Hole 12 12
No Apparent Adverse Event 10 10
Material Fragmentation 10 10
Difficult to Insert 10 10
Failure to Obtain Sample 9 9
Positioning Problem 8 8
Output Problem 8 8
Material Split, Cut or Torn 8 8
Structural Problem 8 8
Activation, Positioning or Separation Problem 7 7
Defective Device 7 7
Device Markings/Labelling Problem 7 7
Failure to Eject 6 6
Component Missing 5 5
Loss of or Failure to Bond 5 5
Difficult to Open or Close 5 5
Defective Component 5 5
Tear, Rip or Hole in Device Packaging 5 5
Loose or Intermittent Connection 5 5
Device Slipped 5 5
Separation Problem 5 5
Leak/Splash 5 5
Device Contaminated During Manufacture or Shipping 4 4
Unsealed Device Packaging 4 4
Dull, Blunt 4 4
Entrapment of Device 4 4
Contamination 4 4
No Display/Image 4 4
Misfire 4 4
Material Frayed 3 3
Shipping Damage or Problem 3 3
Appropriate Term/Code Not Available 3 3
Material Integrity Problem 3 3
Device Damaged by Another Device 3 3
Material Protrusion/Extrusion 3 3
Positioning Failure 3 3
Peeled/Delaminated 3 3
Material Too Rigid or Stiff 2 2
Mechanical Jam 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Premature Activation 2 2
Nonstandard Device 2 2
Display or Visual Feedback Problem 2 2
Migration 2 2
Expiration Date Error 2 2
Activation Problem 2 2
Unraveled Material 2 2
Activation Failure 1 1
Contamination /Decontamination Problem 1 1
Self-Activation or Keying 1 1
Deformation Due to Compressive Stress 1 1
Therapeutic or Diagnostic Output Failure 1 1
Incorrect Measurement 1 1
Unintended Ejection 1 1
Device Dislodged or Dislocated 1 1
Difficult or Delayed Separation 1 1
Degraded 1 1
Failure to Deliver 1 1
Failure to Prime 1 1
Failure to Fire 1 1
Crack 1 1
Packaging Problem 1 1
Fluid/Blood Leak 1 1
Malposition of Device 1 1
Disconnection 1 1
Mechanics Altered 1 1
Difficult or Delayed Activation 1 1
Separation Failure 1 1
Unclear Information 1 1
Accessory Incompatible 1 1
Fitting Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Difficult to Fold, Unfold or Collapse 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 821 821
No Consequences Or Impact To Patient 243 243
Foreign Body In Patient 204 204
No Known Impact Or Consequence To Patient 134 134
Hemorrhage/Bleeding 63 63
Insufficient Information 39 39
Gastrointestinal Hemorrhage 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Pancreatitis 20 20
Device Embedded In Tissue or Plaque 20 20
No Patient Involvement 18 18
Pain 17 17
Pneumothorax 17 17
Abdominal Pain 16 16
Fever 16 16
Unspecified Infection 15 15
Hematoma 12 12
Peritonitis 12 12
No Code Available 12 12
Needle Stick/Puncture 10 10
Perforation 10 10
Abscess 10 10
Inflammation 9 9
Injury 8 8
Pneumonia 7 7
Blood Loss 7 7
Hypoxia 6 6
Unspecified Tissue Injury 6 6
Unspecified Hepatic or Biliary Problem 6 6
Low Blood Pressure/ Hypotension 5 5
Hemoptysis 5 5
Sepsis 5 5
Respiratory Failure 4 4
Radiation Exposure, Unintended 4 4
Thrombocytopenia 4 4
Cough 4 4
Death 4 4
Biliary Cirrhosis 3 3
Cardiac Arrest 3 3
Dyspnea 3 3
Fibrosis 3 3
Obstruction/Occlusion 3 3
Septic Shock 3 3
Vomiting 3 3
Unspecified Gastrointestinal Problem 3 3
Discomfort 2 2
Confusion/ Disorientation 2 2
Perforation of Vessels 2 2
Respiratory Tract Infection 2 2
Bronchospasm 2 2
No Information 2 2
Wheezing 2 2
Hemothorax 2 2
Nausea 2 2
Exposure to Body Fluids 2 2
Bradycardia 2 2
Air Embolism 2 2
Cyst(s) 2 2
Vessel Or Plaque, Device Embedded In 1 1
Dysphagia/ Odynophagia 1 1
Fistula 1 1
Granuloma 1 1
Headache 1 1
Abrasion 1 1
Chest Pain 1 1
Internal Organ Perforation 1 1
Liver Damage/Dysfunction 1 1
Muscle Weakness 1 1
Hepatitis 1 1
Hemostasis 1 1
Pulmonary Emphysema 1 1
Extravasation 1 1
Unspecified Respiratory Problem 1 1
Pleural Empyema 1 1
Syncope/Fainting 1 1
Pseudoaneurysm 1 1
Sedation 1 1
Sore Throat 1 1
Decreased Respiratory Rate 1 1
Sleep Dysfunction 1 1
Dizziness 1 1
Strangulation 1 1
Respiratory Distress 1 1
Muscle Hypotonia 1 1
Cancer Cells Dissemination 1 1
Localized Skin Lesion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Cook Medical Incorporated II May-16-2024
3 Covidien Llc II Aug-05-2020
4 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
5 Olympus Corporation of the Americas III May-19-2023
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