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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 67 67

Device Problems MDRs with this Device Problem Events in those MDRs
Break 371 371
Fracture 270 270
Material Twisted/Bent 203 203
Adverse Event Without Identified Device or Use Problem 155 155
Improper or Incorrect Procedure or Method 128 128
Off-Label Use 114 114
Retraction Problem 85 85
Physical Resistance/Sticking 84 84
Detachment of Device or Device Component 66 66
Difficult to Remove 41 41
Material Perforation 36 36
Material Separation 33 33
Use of Device Problem 32 32
Mechanical Problem 27 27
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 15 15
Device-Device Incompatibility 14 14
Failure to Advance 14 14
Device Fell 12 12
Material Puncture/Hole 11 11
Difficult to Insert 10 10
Material Fragmentation 10 10
Dent in Material 10 10
No Apparent Adverse Event 10 10
Failure to Obtain Sample 9 9
Structural Problem 8 8
Material Split, Cut or Torn 8 8
Positioning Problem 8 8
Output Problem 8 8
Device Markings/Labelling Problem 7 7
Defective Device 7 7
Activation, Positioning or Separation Problem 7 7
Failure to Eject 6 6
Separation Problem 5 5
Difficult to Open or Close 5 5
Tear, Rip or Hole in Device Packaging 5 5
Defective Component 5 5
Component Missing 5 5
Device Slipped 5 5
Loss of or Failure to Bond 5 5
Leak/Splash 5 5
Loose or Intermittent Connection 5 5
Unsealed Device Packaging 4 4
Contamination 4 4
No Display/Image 4 4
Entrapment of Device 4 4
Misfire 4 4
Device Contaminated During Manufacture or Shipping 4 4
Material Integrity Problem 3 3
Material Protrusion/Extrusion 3 3
Device Damaged by Another Device 3 3
Dull, Blunt 3 3
Material Frayed 3 3
Positioning Failure 3 3
Peeled/Delaminated 3 3
Shipping Damage or Problem 3 3
Appropriate Term/Code Not Available 3 3
Mechanical Jam 2 2
Activation Problem 2 2
Migration 2 2
Material Too Rigid or Stiff 2 2
Nonstandard Device 2 2
Premature Activation 2 2
Display or Visual Feedback Problem 2 2
Expiration Date Error 2 2
Unraveled Material 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Device Dislodged or Dislocated 1 1
Separation Failure 1 1
Difficult or Delayed Activation 1 1
Failure to Fire 1 1
Malposition of Device 1 1
Deformation Due to Compressive Stress 1 1
Contamination /Decontamination Problem 1 1
Failure to Deliver 1 1
Fitting Problem 1 1
Unintended Ejection 1 1
Fluid/Blood Leak 1 1
Difficult to Fold, Unfold or Collapse 1 1
Disconnection 1 1
Accessory Incompatible 1 1
Crack 1 1
Degraded 1 1
Failure to Prime 1 1
Incorrect Measurement 1 1
Self-Activation or Keying 1 1
Inadequacy of Device Shape and/or Size 1 1
Difficult or Delayed Separation 1 1
Unclear Information 1 1
Mechanics Altered 1 1
Packaging Problem 1 1
Activation Failure 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 786 786
No Consequences Or Impact To Patient 243 243
Foreign Body In Patient 201 201
No Known Impact Or Consequence To Patient 134 134
Hemorrhage/Bleeding 60 60
Insufficient Information 39 39
Gastrointestinal Hemorrhage 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Device Embedded In Tissue or Plaque 20 20
Pancreatitis 18 18
No Patient Involvement 18 18
Pneumothorax 17 17
Abdominal Pain 16 16
Pain 15 15
Fever 14 14
Unspecified Infection 13 13
Hematoma 12 12
Peritonitis 12 12
No Code Available 12 12
Needle Stick/Puncture 10 10
Abscess 10 10
Inflammation 9 9
Injury 8 8
Perforation 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
Septic Shock 3 3
Vomiting 3 3
Unspecified Gastrointestinal Problem 3 3
Discomfort 2 2
No Information 2 2
Wheezing 2 2
Bronchospasm 2 2
Respiratory Tract Infection 2 2
Obstruction/Occlusion 2 2
Perforation of Vessels 2 2
Confusion/ Disorientation 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
Pseudoaneurysm 1 1
Unspecified Respiratory Problem 1 1
Pleural Empyema 1 1
Syncope/Fainting 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 Covidien Llc II Aug-05-2020
3 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
4 Olympus Corporation of the Americas III May-19-2023
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